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) 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 NIDA and the Center for Substance Abuse Treatment (CSAT). 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 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” clients—many of whom are considered to be “hardcore” drug users. 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 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 rewards 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.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. 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. 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. 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. 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. Table 1 provides an overview of cognitive/behavioral study methodologies and results. 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. 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. 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. Similarly, in the Seattle area, cocaine-using clients cut their average number of days of cocaine use by 71 percent within 6 months. Among high-severity 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. 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 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;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. 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: 65 to 74 percent of those in the community reinforcement group reported 2 or fewer days of cocaine use in the past month. Only 45 percent of those in the counseling control group achieved such gains. Contingency management was also studied independently in an inner-city Baltimore program. 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). 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. Follow-up results obtained 6 months after treatment 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. Given the high rate of cocaine use among methadone clients, 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.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, 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. 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 methadone clients completed the initial 6-month cocaine treatment regimen. 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. 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. 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 research 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. 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 more than a month. 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. 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. 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. 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. 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. 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. 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. 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 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.) 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. And finally, the impact of a day-treatment program (using therapeutic community techniques) was compared with standard methadone maintenance treatment in New York. 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. 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Stone-Washton. “Outpatient Treatment of Cocaine and Crack Addiction: A Clinical Perspective.” National Institute on Drug Abuse Research Monographs # 135. Rockville, Md.: National Institute on Drug Abuse, 1993, pp. 15-30. Wells, E., P. Peterson, R. Gainey, J. David Hawkins, and R. 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. The first copy of each GAO report and testimony is free. Additional copies are $2 each. Orders should be sent to the following address, accompanied by a check or money order made out to the Superintendent of Documents, when necessary. VISA and MasterCard credit cards are accepted, also. Orders for 100 or more copies to be mailed to a single address are discounted 25 percent. U.S. General Accounting Office P.O. Box 6015 Gaithersburg, MD 20884-6015 Room 1100 700 4th St. NW (corner of 4th and G Sts. 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Summary: Pursuant to a congressional request, GAO reviewed the extent to which federally funded cocaine treatment therapies have proven successful and additional research initiatives that are needed to increase knowledge of cocaine treatment effectiveness. GAO found that: (1) cocaine treatment research is still in its early stages; (2) preliminary study results have shown that relapse prevention, community reinforcement and contingency management, and neurobehavioral therapy may produce prolonged periods of abstinence among cocaine users; (3) relapse prevention programs have the highest abstinence rates, followed by community reinforcement and neurobehavioral programs; (4) community reinforcement programs have the highest retention rates, followed by relapse prevention and neurobehavioral programs; (5) pharmacological agents have not proven to be consistently effective in preventing cocaine use, and none have been submitted for Food and Drug Administration approval; (6) animal researchers have demonstrated the positive effects of a new immunization procedure in blocking the stimulant effects of cocaine; (7) few researchers have assessed the effectiveness of acupuncture treatment, but some research findings are favorable; and (8) experts believe that more rigorous treatment evaluation studies that focus on important treatment components, appropriate treatment intensities and durations, and clients' readiness and motivation for treatment are needed before standard cocaine treatment protocols can be formulated.