A Transtheoretical Model Group Therapy for Cocaine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2007-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Developing Computer Based Treatments for Addiction

NCT00586534

Cocaine Addiction

COMPLETED NA

Behavioral Therapy Combined With Carbidopa/Levodopa for the Treatment of Cocaine Dependence

NCT00218075

Cocaine Abuse Cocaine-Related Disorders

COMPLETED PHASE2

A Feasibility Trial for Inhibitory-Control Training to Reduce Cocaine Use

NCT02444208

Cocaine Use Disorder

COMPLETED NA

Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention

NCT02896712

Cocaine-Related Disorders

COMPLETED PHASE2

Effectiveness of Extended Treatments for Drug Dependence

NCT00685659

Cocaine Dependence

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cocaine Use Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Transtheoretical Model Group

Group Type EXPERIMENTAL

Transtheoretical Model Group Therapy

Intervention Type BEHAVIORAL

Education / Advice

Group Type ACTIVE_COMPARATOR

Education & Advice

Intervention Type BEHAVIORAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transtheoretical Model Group Therapy

Intervention Type BEHAVIORAL

Education & Advice

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* (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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No