Clinical trial NCT00178776: A Transtheoretical Model Group Therapy for Cocaine
Official title: A Transtheoretical Model Group Therapy for Cocaine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cocaine Use Disorders
Keywords: Group
Therapy
Cocaine
Drugs
Trial
Outcome
Study
Feasibility
Transtheoretical
Stages
Motivation
Change
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: The University of Texas Health Science Center, Houston
First posted: 2005-09-15
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the feasibility and promise of a recently manualized group therapy based on the Transtheoretical Model for cocaine use disorders.

Detailed description: Cocaine use in the general population is a significant and costly problem. Novel and innovative interventions targeting cocaine abuse are needed. The Transtheoretical Model of behavior change (TTM) offers a comprehensive framework for understanding, measuring, and intervening in behavior change and provides a strong theoretical foundation upon which effective treatments for substance abuse can be developed. The proposed Stage 1 research will pilot test a novel and innovative behavioral group therapy for cocaine users based on the TTM. In Phase 1, investigators will modify the newly developed Group Treatment for Substance Abuse: A Stages-of-Change Therapy Manual (Velasquez, Maurer, Crouch \& DiClemente, 2001) to specifically target cocaine abuse resulting in a twelve-session, group intervention and accompanying therapy manual based on the TTM stages and processes of change: six "early stage" sessions targeting the experiential processes of change, and six "later stage" sessions targeting the behavioral processes of change. Phase 2 will consist of a pilot trial to evaluate the TTM group therapy with cocaine abusing patients. A randomized, controlled, between groups design will be used in which cocaine abusers (N=80) are assigned to one of two group treatment conditions: TTM therapy or Education/Advice. Participants will be recruited from Houston and surrounding communities through the Substance Abuse Research Center at the University of Texas Health Science Center Mental Sciences Institute. We expect the delivery of the TTM therapy for cocaine users to be feasible and acceptable, and to produce significant patient improvement. Cocaine outcomes will be assessed via objective (urine and drug analysis) and self-report measures. This Stage I research will contribute important theoretical and empirical information concerning the promise of a new and innovative intervention for cocaine abusers, and will provide the basis for a larger efficacy trial.

Eligibility criteria: Inclusion Criteria:

Inclusion Criteria: Male and female adults (ages 18-65 years old), of any race, who meet DSM-IV criteria for cocaine abuse or dependence disorder will be recruited. In addition, eligible participants must be:

* (1) judged to be in generally good physical and psychiatric health except for possible acute drug related problems;
* (2) willing and able to participate in the 6-week, group outpatient treatment;
* (3) able to provide the name of at least one person who can generally locate their whereabouts; and
* (4) willing to be followed for 3 months after treatment ends.

Potential subjects with simple drug charges whose legal contacts are willing to forego data revelation will be included. Although cocaine dependence will be the primary drug for which patients are seeking treatment, we will not exclude participants who are abusing additional substances.

Exclusion Criteria:

Individuals will be ineligible for study participation based on the following criteria:

* (1) current diagnosis of an Axis I psychiatric disorder other than cocaine dependence;
* (2) current psychiatric symptoms requiring medication;
* (3) severe medical, cognitive and /or psychiatric impairment that precludes cooperation with study protocol;
* (4) substance withdrawal symptoms requiring medical attention;
* (5) currently receiving other psychosocial therapy for substance abuse with the exception of AA, NA or CA;
* (6) impending incarceration;
* (7) inability to read, write, speak English;
* (8) inability or unwillingness to participate in the 6-week, group outpatient treatment (e.g., halfway house or other aftercare program restrictions).

Primary outcomes:
measure: Urinalysis indicating presence or absence of cocaine metabolites, used to calculate percent days abstinent, collected at intake, once weekly during the 6 week group treatment phase, at post-treatment, and 3 months.
Secondary outcomes:
measure: Secondary Outcome Measures Related to Cocaine and other Drug Use:
measure: 1) Timeline Follow-Back (self-reported use / percent days
measure: abstinent)
measure: 2) Cocaine Craving Worksheet (self report)
measure: 3) Cocaine Negative Consequences Checklist (self report)
measure: 4) Addiction Severity Index (ASI; Interviewer Administered)
measure: 5) Blood Alcohol Breath (biological)
measure: 6) Substance Use Report (self report)
measure: Secondary Outcome Measures Related to Feasibility of the Group Therapy:
measure: 1) Participation / Attendance / Retention
measure: 2) MI Scale (Therapist Adherence)
measure: 3) Treatment Satisfaction Questionnaire
measure: 4) Group Therapy Alliance Scale
measure: 5) Group Atmosphere Scale
measure: 6) Therapist Treatment Evaluation
measure: Secondary Outcome Measures Related to Psychiatric Symptoms:
measure: 1) Beck Depression Inventory (BDI-II)
measure: 2) Brief Symptom Inventory (BSI)
measure: Secondary Outcomes Related to Functioning:
measure: 1) HIV Knowledge Questionnaire
measure: 2) Risk Behavior Assessment
measure: 3) SF-12
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Houston Mental Sciences Institute
state: Texas
Study officials:
affiliation: University of Texas Houston Medical School, Dept. of Family & Community Medicine
name: Mary Marden Velasquez, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Velasquez, M. M., Maurer, G. G., Crouch, C., & DiClemente, C. C. (2001). Group treatment for substance abuse: A stages-of-change therapy manual. New York: Guilford Press.