United States General Accounting Office

GAO Report to Congressional Requesters

June 1996 COCAINE

TREATMENT

Early Results From

Various Approaches

G O A

years

1921 - 1996

GAO/HEHS-96-80

GAO United States

General Accounting Office

Washington, D.C. 20548

Health, Education, and

Human Services Division

B-265688 

June 7, 1996

The Honorable William F. Clinger, Jr.

Chairman

The Honorable Cardiss Collins

Ranking Minority Member

Committee on Government Reform and Oversight

House of Representatives

The Honorable Henry A. Waxman

House of Representatives

Cocaine use in the United States remains a serious and costly epidemic. In

1994, the National Household Survey on Drug Abuse conservatively

estimated that more than three-quarters of a million people had used

cocaine at least once a week within the past year. In 1993, cocaine was

associated with almost 4,000 deaths.1

 Today, an estimated $10 billion per

year is lost in cocaine-related crimes and productivity.2

Although cocaine admissions to state-supported drug abuse treatment

programs between 1985 and 1990 increased dramatically—from almost

39,000 people to more than 200,000—we found in 1991 that an effective

treatment for cocaine addiction had not yet been identified.3

 Today,

public/private expenditures on cocaine-related treatment total about

$1 billion per year.

Because of cocaine’s serious health, economic, and criminal justice

implications for the nation, we have provided a status report on recent

progress made in finding an effective treatment for cocaine users.4

Specifically, we reviewed the various types of federally funded treatment

approaches evaluated over the past 5 years (1991 through 1995) to

(1) determine the extent to which these therapies have proven successful

and (2) identify additional research initiatives necessary to increase our

knowledge of cocaine treatment effectiveness.

1

Drug Abuse Warning Network, Annual Medical Examiner Data 1993, Statistical Series 1, No. 13-B

(Rockville, Md.: Substance Abuse and Mental Health Services Administration, 1995), p. 21.

2

RAND, “Treatment: Effective (But Unpopular) Weapon Against Drugs,” RAND Research Review, Vol.

XIX, No. 1 (Spring 1995), p. 4.

3

Drug Abuse: The Crack Cocaine Epidemic: Health Consequences and Treatment (GAO/HRD-91-55FS,

Jan. 30, 1991), p. 24.

4

“Treatment” does not refer to a singular therapeutic approach. Treatment approaches for individuals

primarily using crack or cocaine, for example, may not be most appropriate for methadone clients who

use cocaine as a secondary drug of choice.

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To conduct our work, we reviewed the literature on cocaine treatment

published from 1991 through 1995, examined records from the National

Institute on Drug Abuse and the Center for Substance Abuse Treatment,

synthesized the latest cocaine treatment research findings related to drug

use and client retention in treatment programs, and assessed the utility of

the various types of treatment approaches. In addition, we interviewed 20

cocaine treatment experts to determine important next steps in the

development of an effective cocaine treatment strategy. (See app. I for

further detail on our methodology.) We did our work from March 1995 to

March 1996 in accordance with generally accepted government auditing

standards.

Results in Brief Given the relative recency of the epidemic, cocaine treatment research is

still in the early stages of development. Attempts to treat cocaine users

with approaches initially developed for other drugs had limited success.

As a result, the federal government began to fund more cocaine-related

treatment studies. Preliminary results of these studies show that three

cognitive/behavioral treatment approaches—relapse prevention,

community reinforcement/contingency management, and neurobehavioral

therapy—have shown early promise with cocaine-abusing and

cocaine-dependent clients, many of whom are classified as “hardcore”

users. Clients treated with these approaches have demonstrated prolonged

periods of cocaine abstinence and high rates of retention in treatment

programs. For example, more than 60 percent of the cocaine-addicted

clients who attended a relapse prevention program in New York were

continuously abstinent from cocaine during the 6- to 24-month follow-up

period; more than 70 percent completed the relapse prevention program.

About half the cocaine-dependent clients receiving community

reinforcement/contingency management in a Vermont outpatient program

remained continuously abstinent through 4 months of treatment;

58 percent completed the entire 6-month course of therapy. And

36 percent of the cocaine-using clients enrolled in a California

neurobehavioral therapy program were abstinent from cocaine 6 months

after entering treatment; the average length of stay in the program was 18

weeks.

Research results on the effectiveness of pharmacological agents have been

less favorable. Twenty major medications for the treatment of cocaine

addiction have been studied by the National Institute on Drug Abuse

(NIDA). While some medications have yielded favorable results in one or

more clinical trials, no medication has demonstrated consistent

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effectiveness in treating cocaine users. Further, no medication has yet

been submitted to the Food and Drug Administration (FDA) for approval

for cocaine treatment.

Cocaine treatment experts emphasized the importance of conducting more

rigorous treatment evaluation studies, including identifying the important

components of treatment, determining appropriate intensities and

durations of treatment, and developing better assessments of clients’

readiness and motivation for treatment.

Background Cocaine addiction has been associated with a variety of serious health

consequences: cardiovascular and respiratory problems, psychiatric

disorders, acquired immunodeficiency syndrome (AIDS), sexually

transmitted diseases, early child development abnormalities, and death.

Because cocaine use became epidemic in the early 1980s, research

opportunities have been limited, and a standard cocaine treatment has not

yet been found. Many substance abuse centers have provided cocaine

users with the same treatment approaches provided to opiate and other

drug users. But these treatments have not been as successful for cocaine

users, who have demonstrated high relapse and dropout rates. The

large-scale Treatment Outcome Prospective Study (TOPS)5

 showed that

about one-third of the clients who reported returning to cocaine use in the

year after treatment began to do so as early as the first week following

treatment termination. Another 25 percent began using the drug within 2

to 4 weeks following treatment termination, for a cumulative first-month

relapse rate of 57 percent. Studies of crack cocaine users found that

47 percent dropped out of therapy between the initial clinic visit and the

first session; three-quarters dropped out by the fifth session.

Because of this lack of treatment success, in the late 1980s and early 1990s

the federal government began playing a more active role in sponsoring

cocaine-related treatment research, principally through NIDA6

 and the

Center for Substance Abuse Treatment (CSAT).7 NIDA is the largest federal

sponsor of substance abuse-related research, conducting work in

treatment and prevention research, epidemiology, neuroscience,

behavioral research, health services research, and AIDS. Since 1991, NIDA

5

TOPS, a national research study of community treatment programs, was initiated in the late 1970s.

The study was conducted by the Research Triangle Institute and supported by NIDA.

6

NIDA is a part of the Department of Health and Human Services’ National Institutes of Health.

7

CSAT is part of the Substance Abuse and Mental Health Services Administration of the Department of

Health and Human Services.

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has funded about 100 cocaine treatment grants and conducted in-house

research through its laboratory facilities. CSAT’s mission includes

developing treatment services, evaluating the effectiveness of these

services, and providing technical assistance to providers and states. Since

1991, CSAT has funded approximately 65 substance abuse research projects

with implications for cocaine addiction treatment.

CSAT cocaine-related data were not yet available at the time this report was

published. Results therefore derive from a literature review of studies

published from 1991 through 1995 and ongoing NIDA-supported cocaine

studies, for which some outcome data were available.

During the 5-year period, two broad types of cocaine treatment

approaches received research emphasis: cognitive/behavioral therapy and

pharmacotherapy. Additionally, acupuncture has emerged as a potential

therapy in the treatment of cocaine. Much of this research has been

conducted in outpatient treatment settings, with a focus on

“cocaine-dependent”8

 clients—many of whom are considered to be

“hardcore” drug users.9

Cognitive/Behavioral

Therapies

Cognitive/behavioral therapies aim to modify the ways clients think, act,

and relate to others, thereby facilitating initial abstinence and a continued

drug-free lifestyle. These therapies include the psychotherapies, behavior

therapies, skills training, and other counseling approaches. Three types of

cognitive/behavioral therapies have received recent attention: relapse

prevention, community reinforcement/contingency management, and

neurobehavioral therapy.

Relapse prevention focuses on helping clients to identify high-risk, or

“trigger,” situations that contribute to drug relapse and to develop

appropriate behaviors for avoiding, or better managing, these situations.

For example, Yale University’s Substance Abuse Treatment Unit has three

principal elements in its 12-week relapse prevention program. First, clients

identify personal triggers by keeping a daily log of the situations in which

they crave the drug. Second, they work with therapists to learn more

effective ways of coping with and avoiding these and other commonly

8

Cocaine dependence is the most serious of all the cocaine diagnoses. Clients diagnosed as

“cocaine-dependent” demonstrate myriad symptoms, including continual cocaine use and withdrawal

symptoms; frequent intoxication; social and occupational problems; and physical, psychological, and

emotional maladies.

9

Treatment of Hardcore Cocaine Users (GAO/HEHS-95-179R, July 31, 1995).

Page 4 GAO/HEHS-96-80 Cocaine Treatment Outcomes
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perceived triggers. And third, therapists help clients extinguish the

drug-craving reactions to these triggers. Clients are taught that relapse is a

process, that social pressures to use drugs can be formidable, and that

lifestyle changes are necessary to discourage future substance abuse.

Community reinforcement/contingency management aims to help the

client achieve initial abstinence as well as an extended drug-free lifestyle.

The therapy consists of several key community-oriented components,

including the participation of a client’s significant other (family member or

friend) in the treatment process; providing management incentives or

rewards10 for drug abstinence; providing employment counseling when

needed; and encouraging client participation in recreational activities as

pleasurable, healthy alternatives to drug use. If clients remain abstinent,

they receive vouchers from the program and earn the right to participate

in desired activities with their significant other. If clients test positive for

drug use, or do not submit to urine testing, negative sanctions are applied

(for example, their vouchers are rescinded). In this manner, community

reinforcement therapy teaches clients about the consequences of their

actions and strengthens family and social ties.

Neurobehavioral treatment is a comprehensive, 12-month outpatient

treatment approach that includes individual therapy, drug education,

client stabilization, and self-help groups. Relapse prevention techniques

are included but constitute only a subset of neurobehavioral treatment.11

Five major stages of recovery are distinguished during the treatment

process—withdrawal, “honeymoon,” “the wall,” adjustment, and

resolution—with emphasis on addressing the client’s behavioral,

emotional, cognitive, and relational problems at each stage of recovery.

For example, in the withdrawal stage, depression, anxiety, self-doubt, and

shame (emotional problems) and concentration difficulties, cocaine

cravings, and short-term memory disruption (cognitive problems) are

addressed. In the first 6 months, individual counseling is emphasized; in

the second 6 months, weekly group counseling is provided, with optional

individual and couple therapy sessions.

10The incentive or reward programs are typically referred to as “contingency management” or “voucher

incentive” programs because vouchers for material goods are provided on a contingency basis (that is,

when tests show that the client has not been using drugs).

11Rewards for remaining abstinent are less emphasized in neurobehavioral therapy, as compared with

community reinforcement.

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Pharmacotherapy Pharmacotherapy involves the use of medications to combat cocaine

abuse and addiction. Recently, NIDA’s pharmacotherapy research has

focused on two objectives: facilitating initial abstinence and supporting an

extended, drug-free lifestyle. To facilitate initial abstinence, research has

focused on medications that treat the withdrawal symptoms of cocaine

addiction and block the euphoric high induced by the drug. To help

maintain an extended drug-free lifestyle, research has focused on blocking

the client’s craving for cocaine, treating the underlying psychopathologies,

and treating the toxic effects of cocaine on the brain.

Acupuncture The use of acupuncture in drug abuse treatment has not been limited to

cocaine addiction. It has also been used during the past 20 years to treat

addictions to opiates, tobacco, and alcohol. A Yale University acupuncture

treatment program for cocaine abuse involved the insertion of needles into

each ear at five strategic points, for a period of 50 minutes per session,

over an 8-week period. Through the first 6 weeks, clients received the

acupuncture therapy 5 days a week; in weeks 7 and 8, treatment was

reduced to 3 days a week. Treatment was provided in a group context.

Three

Cognitive/Behavioral

Therapies Appear

Favorable, but No

Pharmacological

Therapy Has Been

Consistently Effective

The results from NIDA’s cocaine treatment grants are only now becoming

available. Because cocaine therapies are still in their early stages of

development, treatment outcome results cannot be generalized to all

cocaine users. However, early results from a review of the literature and

ongoing NIDA studies reveal the promise of three cognitive/behavioral

approaches to treatment. Moreover, while a pharmacological treatment

has not yet been consistently demonstrated, NIDA is continuing to actively

pursue the biology of cocaine addiction. Further, few well-designed

methodological studies of acupuncture exist, but the limited research in

this area demonstrates at least some positive findings.

Three Cognitive/Behavioral

Treatments Appear

Effective in Outpatient

Settings

Early research indicates relapse prevention, community

reinforcement/contingency management, and neurobehavioral therapy are

potentially promising cocaine-addiction treatment approaches for

promoting extended periods of client abstinence and treatment retention

in outpatient treatment settings.12 Table 1 provides an overview of

cognitive/behavioral study methodologies and results.

12Since journals frequently do not publish studies with nonsignificant findings, we cannot determine

how many attempted cognitive/behavioral studies have proven unsuccessful. This report is based only

on available findings.

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Table 1: Methodology and Results of Illustrative Cognitive/Behavioral Studies

Study

group/publication

date/affiliation

Sample

design/size

Client diagnosis/

demographics Treatment outcomes Study period

Relapse prevention

Carroll and others

(1994); Yale

University, New

Haven, Conn.

Random;

N=121

Clients met criteria for cocaine

dependence

average age: 29

male: 79%

white: about 50%

unemployed: about 40%

single/divorced: about 70%

at least high school graduate:

about 80%

Cocaine-abstinent at least

70% of the time in treatment

12 wks.

Carroll and others

(1991); Yale

University, New

Haven, Conn.

Random; N=42 Clients met criteria for both

cocaine abuse and dependence

average age: 27

male: 67%

white: 67%

average years of education: 13

54% of high-severity cocaine

users were able to attain at

least 3 weeks of continuous

abstinence; only 9% of

high-severity cocaine users

receiving standard

psychotherapy could achieve

this

12 wks.

Washton and

Stone-Washton

(1993); Washton

Institute, New York

Consecutive

admissions;

N=60

Clients met criteria for severe

psychoactive drug dependence

(85% were cocaine addicts)

average age: about 35

male: about 80%

white: about 70%

employed: about 90%

More than 60% abstinent

from cocaine during 6- to

24-month follow-up period

About 28

wks.

Wells and others

(1994);

University of

Washington, Seattle

Alternative

assignment;

N=110

Cocaine was primary drug of

choice

average age: 29

male: 64%

white: 84%

employed full time for past 3

years: 68%

average years of education: 13

Average number of days of

cocaine use cut by 71%

within 6 months

24 wks.

Community reinforcement/contingency management

Higgins and others

(1991); University of

Vermont, Burlington

Consecutive

admissions;

N=25

Clients met criteria for cocaine

dependence

average age: 29

education ≥12 years: 46% 

employed: 62%

single: 54%

46% were continuously

abstinent from cocaine for 8

treatment weeks

12 wks.

(continued)

Page 7 GAO/HEHS-96-80 Cocaine Treatment Outcomes
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Study

group/publication

date/affiliation

Sample

design/size

Client diagnosis/

demographics Treatment outcomes Study period

Higgins and others

(1993); University of

Vermont, Burlington

Random; N=38 Clients met criteria for cocaine

dependence

average age: 29

male: 89%

white: 100%

unmarried: 89%

completed high school: 63%

employed: 42%

42% were continuously

abstinent from cocaine for 16

treatment weeks

24 wks.

Contingency management only

Silverman and

others (1994, 1995);

Johns Hopkins

University, Baltimore

Frequency of

cocainepositive urines

during initial 5

weeks of

methadone

therapy; N=37

Clients met criteria for heroin

and cocaine dependence

average age: 36

black: 26%

married: 16%

completed at least high school:

74%

employed full time: 47%

Nearly 50% of the clients

receiving vouchers for

cocaine-free urines remained

continuously abstinent from

cocaine for 7 to 12 weeks

12 wks.

Neurobehavioral therapy

Shoptaw and others

(1994); Matrix

Institute, Los

Angeles

Random;

N=146

Clients met criteria for stimulant

abuse or dependence

average age: 31

male: 84%

white: 63%

Hispanic: 25%

average years of education: 13

unmarried: 78%

36% remained continuously

abstinent from cocaine for at

least 8 treatment weeks; 38%

were abstinent from cocaine

at 6-month follow-up

12 mos.

Rawson and others

(1993); Matrix

Institute, Los

Angeles

Open trial;

N=486

Cocaine-using clients

average age: 30

male: 74%

white: 76%

average years of education: 14

single: 54%

At least 40% at two treatment

sites remained continuously

abstinent from cocaine

through 6 months of treatment

6 mos.

Rosenblum and

others (1994);

National

Development and

Research Institutes,

Inc., New York

Random; N=77 Methadone clients who met

criteria for cocaine dependence

age 24 to 43: 87%

Hispanic: 64%

black: 31%

unemployed: 77%

married/common law: 38%

completed at least high school:

42%

Clients attending 3 to 19

sessions reduced past-month

cocaine use by 5%; those

attending 85 to 133 sessions

reduced past-month cocaine

use by 60%

6 mos.

(continued)

Page 8 GAO/HEHS-96-80 Cocaine Treatment Outcomes
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Study

group/publication

date/affiliation

Sample

design/size

Client diagnosis/

demographics Treatment outcomes Study period

Magura and others

(1994); National

Development and

Research Institutes,

Inc., New York

Random; N=62 Methadone clients who met

criteria for cocaine dependence

average age: 36

male: 56%

Hispanic: 72%

black: 23%

married/common law: 49%

completed at least high school:

38%

Group demonstrated

significant decrease in

cocaine use between

entering treatment and

6-month follow-up; clients not

receiving neurobehavioral

therapy showed no

significant decrease

6 mos.

Relapse Prevention Clients who received relapse prevention treatment have demonstrated

favorable abstinence rates not only during the period of treatment, but

during follow-up periods as well. Client treatment retention results also

appear to be favorable. For example, cocaine-dependent clients

participating in a 12-week Yale University program focusing on relapse

prevention were able to remain cocaine abstinent at least 70 percent of the

time while in treatment.13 A year after treatment, gains were still evident:

clients receiving relapse prevention treatment and a placebo medication

were reported to have used cocaine on average fewer than 3 days in the

past month.14

Positive outcome results were also found in two other programs: more

than 60 percent of the primarily middle-class, cocaine-addicted clients

attending a relapse prevention program at the Washton Institute in New

York were abstinent from cocaine during the 6-to 24-month follow-up

period.15 Similarly, in the Seattle area, cocaine-using clients cut their

average number of days of cocaine use by 71 percent within 6 months.16

13Kathleen Carroll, Bruce Rounsaville, Lynn Gordon, Charla Nich, Peter Jatlow, Roseann Bisighini, and

Frank Gawin, “Psychotherapy and Pharmacotherapy for Ambulatory Cocaine Abusers,” Archives of

General Psychiatry, Vol. 51 (1994), pp. 177-187.

14Unpublished 12-month data provided by Kathleen Carroll and Charla Nich, Oct. 19, 1995.

15Arnold Washton and Nannette Stone-Washton, “Outpatient Treatment of Cocaine and Crack

Addiction: A Clinical Perspective,” National Institute on Drug Abuse Research Monograph #135

(Rockville, Md.: National Institute on Drug Abuse, 1993), pp. 15-30.

16Elizabeth Wells, Peggy Peterson, Randy Gainey, J. David Hawkins, and Richard Catalano, “Outpatient

Treatment for Cocaine Abuse: A Controlled Comparison of Relapse Prevention and Twelve-Step

Approaches,” American Journal of Drug and Alcohol Abuse, Vol. 20, No. 1 (1994), pp. 1-17.

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Among high-severity17 cocaine addicts participating in another Yale

program, it was also found that 54 percent receiving relapse prevention

therapy were able to attain at least 3 weeks of continuous abstinence,

while only 9 percent of those receiving the interpersonal psychotherapy

could remain abstinent for that period of time.18

Retention rates were also favorable: 67 percent of the relapse prevention

clients completed the entire 12-week Yale program and more than

70 percent completed the Washton program.

Community

Reinforcement/Contingency

Management

Community reinforcement/contingency management programs have also

appeared promising in fostering abstinence and retaining clients in

treatment. Almost one-half (46 percent) of the cocaine-dependent clients

participating in a 12-week community reinforcement/contingency

management program at the University of Vermont were able to remain

continuously abstinent from cocaine through 2 months of treatment;19

when the program was extended to 24 weeks, 42 percent of the

participating cocaine-dependent subjects were able to achieve 4 months of

continuous abstinence.20 By comparison, only 5 percent of those in the

control group receiving drug abuse counseling alone could remain

continuously abstinent for the entire 4 months.

A year after clients began treatment, community reinforcement/

contingency management treatment effects were still evident:21 65 to

74 percent22 of those in the community reinforcement group reported 2 or

17“Severity” is defined in terms of median splits on the drug use subscale of the Addiction Severity

Index. Subjects in the high-severity group demonstrated high weekly use of cocaine (4.9 grams/week);

were chronic drug users (43.2 months of regular use); and had high levels of family/social,

occupational, and legal problems.

18Kathleen Carroll, Bruce Rounsaville, and Frank Gawin, “A Comparative Trial of Psychotherapies for

Ambulatory Cocaine Abusers: Relapse Prevention and Interpersonal Psychotherapy,” American

Journal of Drug and Alcohol Abuse, Vol. 17, No. 3 (1991), pp. 229-47.

19Stephen Higgins, Dawn Delaney, Alan Budney, Warren Bickel, John Hughes, Florian Foerg, and

James Fenwick, “A Behavioral Approach to Achieving Initial Cocaine Abstinence,” American Journal

of Psychiatry, Vol. 148, No. 9 (1991), pp. 1218-24. To test the accuracy of self-reported client data,

researchers at the University of Vermont compared self-reports to urine test results. In 98 percent of

the cases in which a client indicated nonuse, urinalysis data confirmed the report.

20Stephen Higgins, Alan Budney, Warren Bickel, John Hughes, Florian Foerg, and Gary Badger,

“Achieving Cocaine Abstinence With a Behavioral Approach,” American Journal of Psychiatry, Vol.

150, No. 5 (1993), pp. 763-69.

21Unpublished 12-month data provided by Stephen Higgins, June 6, 1995.

22The percentage range represents outcome results across two clinical trials.

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fewer days of cocaine use in the past month. Only 45 percent of those in

the counseling control group achieved such gains.23

Contingency management was also studied independently in an inner-city

Baltimore program.24,25 Positive results were found when tying the

12-week voucher reward system to cocaine drug testing. Nearly half of the

cocaine-abusing and cocaine-dependent clients (who were also heroin

users) given vouchers for cocaine-free urine test results were able to

remain continuously abstinent for 7 to 12 weeks. Among clients receiving

vouchers unpredictably—not tied to urine test results—only 1 client

achieved abstinence for more than 2 weeks.

Client treatment retention was also high. Within the Vermont community

reinforcement/contingency management group, 85 percent of the clients

completed the 12-week program, compared with only 42 percent of those

in the 12-step drug counseling control group. The 24-week program was

completed by about five times as many clients in the community

reinforcement group as those receiving drug counseling therapy

(58 percent versus 11 percent).

Neurobehavioral Therapy Several programs have demonstrated that a neurobehavioral therapeutic

approach can also be effective in promoting cocaine abstinence and

treatment retention. Thirty-six percent of the cocaine-abusing and

cocaine-dependent clients participating in a neurobehavioral therapy

program through the Matrix Institute in California succeeded in remaining

continuously abstinent from cocaine for at least 8 consecutive weeks

while in treatment.26 Follow-up results obtained 6 months after treatment

23Since not every client was using cocaine the same number of times per month at the point of

treatment entry, Higgins calculated a magnitude-of-change score between treatment entry and

12-month follow-up for each group. At intake, 10 to 21 percent of community reinforcement clients

reported ≤ 2 days of cocaine use in the past month; 12 months after treatment entry, 65 to 74 percent

were using ≤ 2 days in the past month, for a positive gain of 53 to 55 percent. This gain was higher than

that experienced by the drug counseling control group (29 percent).

24K. Silverman, R.K. Brooner, I.D. Montoya, C.R. Schuster, and K.L. Preston, “Differential Reinforcement

of Sustained Cocaine Abstinence in Intravenous Polydrug Abusers.” In L.S. Harris (ed.), Problems of

Drug Dependence 1994: Proceedings of the 56th Annual Scientific Meeting, The College on Problems

of Drug Dependence. National Institute on Drug Abuse Research Monograph #153 (Rockville, Md.:

National Institute on Drug Abuse Research, 1995), p. 212.

25K. Silverman, C.J. Wong, A. Umbricht-Schneiter, I.D. Montoya, C. R. Schuster, and K.L. Preston,

“Voucher-Based Reinforcement of Cocaine Abstinence: Effects of Reinforcement Schedule.” In L.S.

Harris (ed.), Problems of Drug Dependence 1995: Proceedings of the 57th Annual Scientific Meeting,

The College on Problems of Drug Dependence. National Institute on Drug Abuse Research Monograph,

in press. Also cited in NIDA Notes, Vol. 10, No. 5 (Sept./Oct. 1995), pp. 10, 14.

26Steven Shoptaw, Richard Rawson, Michael McCann, and Jeanne Obert, “The Matrix Model of

Outpatient Stimulant Abuse Treatment: Evidence of Efficacy,” Journal of Addictive Diseases, Vol. 13,

No. 4 (1994), pp. 129-41.

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entry showed that 38 percent of these clients still tested drug free. In a

separate examination of two neurobehavioral outpatient treatment sites,

at least 40 percent of the cocaine clients in each site remained

continuously abstinent through the entire 6-month course of therapy.27

Given the high rate of cocaine use among methadone clients,28,29,30 the

neurobehavioral model was adapted in New York for use among

methadone clients meeting the diagnostic criteria for cocaine dependence.

In an intensive 6-month program, a strong relationship was found between

the number of treatment sessions attended and cocaine use reduction.31

Clients attending 3 to 19 sessions experienced a 5-percent reduction in

cocaine use during the previous month. Those attending 85 to 133 sessions

experienced a 60-percent reduction in their past 30-day use of cocaine. In

another New York study with cocaine-addicted methadone clients,32 those

clients receiving neurobehavioral treatment demonstrated a significant

decrease in cocaine use between entering treatment and 6-month

follow-up; the control group showed no statistically significant decrease.33

Neurobehavioral retention rates also proved favorable. In the California

study of two treatment sites, clients were retained an average of about 5

months and 3 months, respectively; in the other California study, the

average length of stay for cocaine users was about 4-1/2 months. For the

first New York study, a total of 61 percent of the cocaine-dependent

27Richard Rawson, Jeanne Obert, Michael McCann, and Walter Ling, “Neurobehavioral Treatment for

Cocaine Dependency: A Preliminary Evaluation,” Cocaine Treatment: Research and Clinical

Perspectives. National Institute on Drug Abuse Research Monograph #135 (Rockville, Md.: National

Institute on Drug Abuse, 1993), pp. 92-115.

28Methadone Maintenance: Some Treatment Programs Are Not Effective; Greater Federal Oversight

Needed (GAO/HRD-90-104, Mar. 22, 1990), p. 18.

29S. Magura, Q. Siddiqi, R. Freeman, and D. Lipton, “Changes in Cocaine Use After Entry to Methadone

Treatment,” Journal of Addictive Diseases, Vol. 10, No. 4 (1991), pp. 31-45.

30W. Condelli, J. Fairbank, M. Dennis, and J. V. Rachal, “Cocaine Use By Clients in Methadone

Programs: Significance, Scope, and Behavioral Interventions,” Journal of Substance Abuse Treatment,

Vol. 8 (1991), pp. 203-12.

31Andrew Rosenblum, Stephen Magura, Jeffrey Foote, Michael Palij, Leonard Handelsman, Meg

Lovejoy, and Barry Stimmel, “Treatment Intensity and Reduction in Drug Use for Cocaine-Dependent

Methadone Patients: A Dose Response Relationship.” Prior version of this paper was presented at the

American Society of Addiction Medicine Annual Conference, New York, Apr. 1994.

32Stephen Magura, Andrew Rosenblum, Meg Lovejoy, Leonard Handelsman, Jeffrey Foote, and Barry

Stimmel, “Neurobehavioral Treatment for Cocaine-Using Methadone Patients: A Preliminary Report,”

Journal of Addictive Diseases, Vol. 13, No. 4 (1994), pp. 143-60.

33At treatment entry, 100 percent of both the neurobehavioral and control groups were using cocaine.

But at 6-month follow-up, only 64 percent of the former had used cocaine, compared with 84 percent

of the control group.

Page 12 GAO/HEHS-96-80 Cocaine Treatment Outcomes
B-265688 

methadone clients completed the initial 6-month cocaine treatment

regimen.

No Effective Medication

for Treating Cocaine

Addiction Has Yet Been

Found

Currently, there is no FDA-approved pharmacotherapy for cocaine

addiction. While some medications have proven successful in one or more

clinical trials, no medication has demonstrated “substantial efficacy” once

subjected to several rigorously controlled trials.

Twenty major medications have been considered by NIDA’s Medications

Development Division (MDD). Fourteen have been tested with humans, five

are in the animal experimentation stage, and one is being tested on both

humans and animals for different treatment effects. Table 2 provides a

summary of the medications tested, their current phase of testing, and

therapeutic uses.

Table 2: Medications Tested for the

Treatment of Cocaine Medication Therapeutic use

Human trials

Amantadine Supports maintenance therapy

Bromocriptine Supports maintenance therapy

Buprenorphine Blocks euphoria

Bupropion Helps achieve initial abstinence

Carbamazepine Treats withdrawal

Desipramine Treats withdrawal

Fluoxetine Treats withdrawal

Flupenthixol Treats withdrawal

Imipramine Treats withdrawal

L-DOPA Serves as replacement therapy

L-tryptophan Serves as functional antagonist

Mazindol Treats withdrawal

Methylphenidate Supports maintenance therapy

Nifedipine Blocks euphoria

Sertraline Treats withdrawal

Animal trials

Diltiazem Blocks euphoria/treats cocaine cardiotoxicity

Nifedipine Treats cocaine cardiotoxicity

Monoclonal antibodies Serves as functional blocker

SCH23390 Blocks euphoria

Sulpiride Blocks euphoria

Verapamil Blocks euphoria/treats cocaine cardiotoxicity

Page 13 GAO/HEHS-96-80 Cocaine Treatment Outcomes
B-265688 

Of the 20 medications tested, MDD has labeled 6 as “disappointing”:

buprenorphine, carbamazepine, desipramine, imipramine, mazindol, and

nifedipine. The remainder are still under investigation, but numerous

clinical trials thus far have yielded mixed results. For example, a 1992

study by Ziedonis and Kosten indicated that amantadine was effective in

reducing cocaine craving; yet a 1989 study by Gawin, Morgan, Kosten, and

Kleber indicated that this medication was not as effective as a placebo in

reducing cocaine craving.34 Additional pharmacological studies are cited in

the bibliography.

Thus, no pharmacotherapy for cocaine exists that compares with

methadone, which reduces heroin craving, enables the client to stabilize

psychological functioning, and eliminates or reduces the heroin

withdrawal process. Nor has any medication proven effective as a

supportive therapy, to be used in combination with one or more

cognitive/behavioral therapies, to enhance cocaine abstinence.

But recent animal research35 has demonstrated the positive effects of a

new immunization procedure in protecting rats against the stimulant

effects of cocaine. When vaccinated, rats produced antibodies that acted

like biological “sponges” or blockers, diminishing by more than 70 percent

the amount of cocaine reaching the brain. As a result, inoculated rats

experienced significantly lower cocaine stimulation levels than

noninoculated rats. Further research needs to be conducted before human

clinical trials can be planned.

Few Well-Designed

Acupuncture Outcome

Research Studies Exist

Some treatment centers are now offering acupuncture as therapy for

cocaine and other substance abuse. For example, in 1993, the Lincoln

Hospital Substance Abuse Treatment Clinic treated about 250 clients per

day with acupuncture therapy. To date, however, few well-designed

evaluation studies have assessed the utility of acupuncture treatment.

But the limited research findings are somewhat favorable. Almost

90 percent of a group of inner-city, cocaine-dependent methadone clients

who completed an 8-week course of acupuncture remained abstinent for

34Tabular summaries of cocaine pharmacological studies provided by the Regulatory Affairs Branch,

Medications Development Division, NIDA, Dec. 28, 1994.

35“NIDA Media Advisory,” Dec. 14, 1995.

Page 14 GAO/HEHS-96-80 Cocaine Treatment Outcomes
B-265688 

more than a month.36 These individuals had been regular users of cocaine,

on average, for 13 years. Fifty percent of the clients, however, did not

complete the 2-month program. Inner-city, cocaine-dependent methadone

clients participating in a second acupuncture research study decreased

their frequency of cocaine use and craving for the drug after just 6 weeks

of therapy.37 These participants had been regular cocaine users, on

average, for more than 10 years. And chronic crack cocaine users

demonstrated a statistically significant tendency toward greater day-to-day

reductions in cocaine use during a 4-week course of acupuncture therapy.

But they did not differ from the control group in their overall percentage

of drug-free test results.38,39

More Research Is

Needed to Formulate

a Standard Cocaine

Treatment Approach

Much has been learned about cocaine treatment in the 15-year period

since the epidemic began. Studies show that client abstinence and

retention rates can be positively affected through a number of promising

treatment approaches.40 However, according to cocaine treatment experts,

additional research is needed before standard, generalizable cocaine

treatment strategies can be formulated for cocaine addicts of varying

demographic and clinical groups. (See app. II for a summary of the

experts’ suggestions.)

In the cognitive/behavioral area, for example, the experts indicated a need

for additional clinical research aimed at identifying the important

components of promising treatment practices, further development and

testing of client reward systems (contingency contracting), additional

study of the triggers that promote relapse, and identification of

appropriate intensities and durations of treatment.

36Arthur Margolin, S. Kelly Avants, Patrick Chang, and Thomas Kosten, “Acupuncture for the

Treatment of Cocaine Dependence in Methadone-Maintained Patients,” The American Journal on

Addictions, Vol. 2, No. 3 (1993), pp. 194-201.

37S. Kelly Avants, Arthur Margolin, Patrick Chang, Thomas Kosten, and Stephen Birch, “Acupuncture

for the Treatment of Cocaine Addiction: Investigation of a Needle Puncture Control,” Journal of

Substance Abuse Treatment, Vol. 12, No. 3 (1995), pp. 195-205.

38Vincent Brewington, Michael Smith, and Douglas Lipton, “Acupuncture as a Detoxification

Treatment: An Analysis of Controlled Research,” Journal of Substance Abuse Treatment, Vol. 11, No. 4,

pp. 289-307.

39Douglas Lipton, Vincent Brewington, and Michael Smith, “Acupuncture and Crack Addicts: A

Single-Blind Placebo Test of Efficacy,” Presentation at Advances in Cocaine Treatment, NIDA

Technical Review Meeting, Aug. 1990.

40In addition to investigation of these specific treatment approaches, research is also being conducted

more globally in institutional settings (see app. III).

Page 15 GAO/HEHS-96-80 Cocaine Treatment Outcomes
B-265688 

In the pharmacological area, the experts recommended further

development and testing of medications to block the effects of cocaine

and reduce craving, examining the human toxicity effects of

pharmaceutical agents found useful in animal experiments, conducting

outcome studies combining cognitive/behavioral and pharmacological

therapies, developing maintenance medications, and conducting more

longitudinal studies of medication treatment effectiveness.

The experts also highlighted the need for further research into

client/treatment matching, client retention, client readiness and motivation

for treatment, and long-term treatment outcomes.

Summary Three cognitive/behavioral treatment approaches—relapse prevention,

community reinforcement/contingency management, and neurobehavioral

therapy—have demonstrated favorable results in the treatment of cocaine

addiction. Preliminary findings show that clients exposed to these

therapies were able to remain abstinent and in treatment for prolonged

periods of time. These findings are particularly encouraging since initial

treatment approaches of the early 1980s were not very successful.

Although currently an insufficient number of studies within each

treatment area exists to draw definitive conclusions about the utility or

generalizability of any specific treatment approach, more study results

should become available within the next few years. Research experts

agreed that continued research and study are needed to enhance and

confirm or deny these early results.

Agency Comments NIDA reviewed a draft of this report and provided comments, which are

included in appendix IV. NIDA officials generally agreed with our

conclusions on the effectiveness of cognitive/behavioral and

pharmacological therapies for cocaine treatment. However, they felt we

were too positive about the early results of acupuncture treatment,

particularly given the lack of well-designed outcome studies. We agreed

with NIDA on this point and reworded our statements on acupuncture’s use

in treating cocaine addiction to clarify the preliminary nature of the results

and the need for more well-controlled studies. Other technical and

definitional changes were incorporated, as appropriate.

Page 16 GAO/HEHS-96-80 Cocaine Treatment Outcomes
B-265688 

We are sending copies of this report to the Director of the National

Institute on Drug Abuse, the Director of the Center for Substance Abuse

Treatment, and other interested parties. We will also make copies

available to others on request. If you have any questions about this report,

please call me at (202) 512-7119 or Jared Hermalin, the

Evaluator-in-Charge, at (202) 512-3551. Dwayne Simpson of Texas

Christian University and George DeLeon of the National Development and

Research Institutes served as independent reviewers. Mark Nadel and

Karen Sloan also contributed to this report.

Sarah F. Jaggar

Director, Health Financing and

 Public Health Issues

Page 17 GAO/HEHS-96-80 Cocaine Treatment Outcomes
Contents

Letter 1

Appendix I 

Methodology

20

Appendix II 

Research Initiatives

Necessary for

Increasing

Understanding of

Cocaine Treatment

Effectiveness

23

Appendix III 

Cocaine Outcomes by

Treatment Setting

25

Appendix IV 

Comments From the

National Institute on

Drug Abuse

27

Bibliography 29

Tables Table 1: Methodology and Results of Illustrative

Cognitive/Behavioral Studies

7

Table 2: Medications Tested for the Treatment of Cocaine 13

Abbreviations

AIDS acquired immunodeficiency syndrome

CSAT Center for Substance Abuse Treatment

FDA Food and Drug Administration

MDD Medications Development Division

NIDA National Institute on Drug Abuse

TOPS Treatment Outcome Prospective Study

Page 18 GAO/HEHS-96-80 Cocaine Treatment Outcomes
Page 19 GAO/HEHS-96-80 Cocaine Treatment Outcomes
Appendix I 

Methodology

To determine the extent to which cocaine therapies have proven

successful, we identified studies with current reportable data on two

outcome variables: drug abstinence and treatment retention. We reviewed

the literature published between 1991 and 1995; examined Center for

Substance Abuse Treatment (CSAT) and National Institute on Drug Abuse

(NIDA) agency records of cocaine-related grants awarded during this time

period; and, as necessary, contacted project investigators.

The approximately 65 cocaine-related grants supported by CSAT were still

in progress at the time of this writing; neither abstinence nor retention

data were available for inclusion in this report. Most of the approximately

100 NIDA longitudinal studies were also in progress. Our report was

therefore based on articles published during the 5-year period,

unpublished documents provided by federal drug agencies, and those

available abstinence and retention findings from ongoing NIDA-supported

studies.

We classified the studies from each of these sources into two treatment

categories: cognitive/behavioral and pharmacological treatments. We then

classified the cognitive/behavioral studies as either relapse prevention,

community reinforcement/contingency management, or neurobehavioral

therapy and the pharmacological studies by drug type.

We then reviewed those studies with reported abstinence and/or retention

findings within each treatment area to determine the utility of each

approach. In making determinations about treatment utility, we gave

consideration to whether or not the studies had appropriate designs for

determining treatment effectiveness.

The intent of this report was not to provide an exhaustive evaluation

synthesis of the cocaine studies currently available (particularly given the

limited number of studies available), nor to assess the qualitative

methodology of each study. Rather, the objective was to determine

whether particular treatment approaches appeared favorable or

promising, and to provide examples of such favorable cocaine treatment

approaches in the text. Given the relatively limited number of studies

available, additional work is necessary before determinations can be made

about the utility of any treatment approach for specific demographic and

clinical groups.

To identify additional research initiatives necessary for increasing our

knowledge of cocaine treatment effectiveness, we conducted telephone

Page 20 GAO/HEHS-96-80 Cocaine Treatment Outcomes
Appendix I 

Methodology

interviews with 20 cocaine treatment experts. Each of the experts we

selected was either a principal investigator or coinvestigator on a

currently funded cocaine-related federal grant or contract, a member of a

federal cocaine grant/contract review committee within the past 2 years,

or an author of at least two cocaine peer-reviewed publications. The

names and affiliations of the 20 experts who participated are listed below.

(Two additional individuals chose not to participate.)

M. Douglas Anglin

University of California, Los Angeles

Neuropsychiatric Institute

Kathleen Carroll

Yale University

George DeLeon

National Development and Research Institutes

Frank Gawin

University of California, Los Angeles

Dean Gerstein

National Opinion Research Center

Edward Gottheil

Thomas Jefferson University

John Grabowski

University of Texas

Health Science Center

Barbara Havassy

University of California, San Francisco

Stephen Higgins

University of Vermont

Herbert Kleber

Columbia University

Thomas Kosten

Yale University

Page 21 GAO/HEHS-96-80 Cocaine Treatment Outcomes
Appendix I 

Methodology

William McAuliffe

Harvard University

Thomas McLellan

Philadelphia Veterans Administration Medical Center

University of Pennsylvania

Stephen Magura

National Development and Research Institutes

Jerome Platt

Medical College of Pennsylvania and Hahnemann University

Richard Rawson

Matrix Institute on Addictions

Harvey Siegel

Wright State University

Dwayne Simpson

Texas Christian University

Michael Thase

University of Pittsburgh

Arnold Washton

Washton Institute

Page 22 GAO/HEHS-96-80 Cocaine Treatment Outcomes
Appendix II 

Research Initiatives Necessary for

Increasing Understanding of Cocaine

Treatment Effectiveness

Following are the responses of the 20 treatment experts to the GAO

question, “What important knowledge gaps remain in our understanding of

cocaine treatment effectiveness in each of the following two areas:

cognitive/behavioral and pharmacological interventions?” Relevant

individual response items were placed into six clinical and methodological

categories: cognitive/behavioral issues, pharmacological issues, the

cognitive/behavioral and pharmacological synergy, clinical

assessment/outcome issues, population subgroup treatment issues, and

methodological issues. The frequency count for each category is also

provided.

Cognitive/Behavioral

Issues

Identifying important components of promising treatment practices,

developing and testing contingency contracting strategies, recognizing the

triggers of relapse, determining appropriate intensity and duration of

treatment protocols, assessing the utility of low-intensity treatments,

defining and increasing important aspects of social and community

support, and codifying appropriate treatment practices.

Categorical frequency: 12.

Pharmacological Issues Developing drugs to diminish the craving for cocaine; developing drugs to

block the effects of cocaine; developing maintenance medication for

continued relapse prevention; examining the utility of multiple untried

drugs indicated in the Physician’s Desk Reference; longitudinally testing

the effects of drugs; assessing human toxicity effects of drugs found useful

in animal experiments; developing detoxification medication; and further

investigating vaccines, agonists, and antagonists.

Categorical frequency: 14.

Cognitive/Behavioral and

Pharmacological Synergy

Testing drugs as adjuncts to cognitive/behavioral therapies, determining

the impact of combined drug and cognitive/behavioral therapies on the

extension of relapse prevention, and assessing the combination of drugs

and cognitive/behavioral therapies that works best for various subgroups.

Categorical frequency: 6.

Page 23 GAO/HEHS-96-80 Cocaine Treatment Outcomes
Appendix II 

Research Initiatives Necessary for

Increasing Understanding of Cocaine

Treatment Effectiveness

Clinical

Assessment/Outcome

Issues

Improving the effectiveness of recruitment and retention of clients in

treatment, better assessing readiness and motivation for treatment, better

assessing impact of dual disorders on treatment outcome, investigating

unknown long-term drug treatment outcomes, developing information on

long-term incentives for maintaining drug abstinence, increasing

knowledge about “aftercare” treatment planning, increasing knowledge of

treatment outcome for managed care/health maintenance organizations to

plan client treatments, and improving the effectiveness of outpatient care.

Categorical frequency: 11.

Population Subgroup

Treatment Issues

Better matching client needs to treatment services as well as determining

which clients do well with specific therapies, what groups can be

effectively treated, who can become abstinent without use of drugs, what

subgroups learn or do not learn about relapse risk factors in treatment

settings, and what educational/IQ levels are necessary for making effective

use of cognitive approaches.

Categorical frequency: 10.

Methodological Issues Need for the following: more clinical trials to demonstrate the efficacy of

basic treatment services; testing treatments on a wider population of

cocaine users; more systematic data collection; improved technology for

conducting randomized, longitudinal trials; evaluating the patient selection

process (volunteers may represent a biased sample); and conducting

cost-effectiveness studies.

Categorical frequency: 7.

Page 24 GAO/HEHS-96-80 Cocaine Treatment Outcomes
Appendix III 

Cocaine Outcomes by Treatment Setting

In addition to the study of particular treatment approaches (such as

relapse prevention, community reinforcement/contingency management,

and neurobehavioral therapy), researchers are also beginning to examine

the results of cocaine treatment in different types of settings (that is,

outpatient, inpatient, day-hospital, and therapeutic communities). In

general, outpatient and day-hospital stays tend to be less costly than

extended inpatient stays. Results of recent studies suggest that cocaine

treatment can be effective in these less costly settings, but further

replication is necessary before any firm conclusions can be drawn.

Clients attending a California-based Veterans Administration intensive

outpatient program with a self-help component were able to remain

cocaine abstinent 73 percent of the time, when followed up 24 months

after treatment admission.41 This result was comparable to that found

among clients attending a more costly program consisting of both an

inpatient stay and a highly intensive outpatient/self-help program. The

California-based program results also surpassed those achieved by clients

who participated in both an inpatient and a low-intensity

outpatient/self-help program (56 percent). These results point to the

conclusion that clients with a cocaine problem may be able to do quite

well in an intensive outpatient setting that consists of at least four visits

per month for at least 6 months.

In a second California study, cocaine-dependent inpatients fared better

than outpatients at both 6 and 12 months following treatment entry,

although both groups fared well.42 Allowing for up to two slips (or brief

episodes of use), at the 6-month period the inpatient abstinence rate was

79 percent, whereas the outpatient rate was 67 percent. At the 12-month

period, the abstinence rates were 72 percent and 50 percent, respectively.

The effects of day-hospital versus inpatient treatment were assessed in

Philadelphia.43 About one-half (53 percent) of those cocaine-dependent

clients attending a day-hospital program were able to remain continuously

abstinent throughout the 6 months following treatment completion. This

rate was comparable to that of inpatients: 47 percent.

41M. Elena Khalsa, Alfonso Paredes, and M. Douglas Anglin, “A Natural History Assessment of Cocaine

Dependence: Pre- and Post-Treatment Behavioral Patterns,” unpublished manuscript.

42Unpublished inpatient-outpatient data provided by Barbara Havassy, Sept. 25, 1995.

43Arthur L. Alterman, Charles P. O’Brien, A. Thomas McLellan, Donna S. August, Edward C. Snider,

Marian Droba, James W. Cornish, Charles P. Hall, Arnold H. Raphaelson, and Francis X. Schrade,

“Effectiveness and Costs of Inpatient Versus Outpatient Hospital Cocaine Rehabilitation,” The Journal

of Nervous and Mental Disease, Vol. 182, No. 3 (1994), pp. 157-63.

Page 25 GAO/HEHS-96-80 Cocaine Treatment Outcomes
Appendix III 

Cocaine Outcomes by Treatment Setting

And finally, the impact of a day-treatment program (using therapeutic

community techniques) was compared with standard methadone

maintenance treatment in New York.44 At 6-month follow-up, only

19.1 percent of those remaining in the day-treatment program had used

cocaine during the past 30 days. These results were substantially better

than those of participants in the standard methadone maintenance

treatment program, where 41.8 percent were using cocaine at 6-month

follow-up. The day-treatment therapeutic community group also

demonstrated significantly greater reductions in heroin use, needle use,

criminal activity, and psychological dysfunction scores.

44George DeLeon, Graham Staines, Theresa Perlis, Stanley Sacks, Karen McKendrick, Robert Hilton,

and Ronald Brady, “Therapeutic Community Methods in Methadone Maintenance (Passages): An Open

Clinical Trial,” Drug and Alcohol Dependence, Vol. 37 (1995), pp. 45-57.

Page 26 GAO/HEHS-96-80 Cocaine Treatment Outcomes
Appendix IV 

Comments From the National Institute on

Drug Abuse

Page 27 GAO/HEHS-96-80 Cocaine Treatment Outcomes
Appendix IV 

Comments From the National Institute on

Drug Abuse

Page 28 GAO/HEHS-96-80 Cocaine Treatment Outcomes
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