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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) The University of Texas Health Science Center, Houston |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00178776 |
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.
Condition | Intervention |
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Cocaine Use Disorders |
Behavioral: Transtheoretical Model Group Therapy Behavioral: Education & Advice |
Study Type: | Interventional |
Study Design: | Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Transtheoretical Model Group Therapy for Cocaine |
Estimated Enrollment: | 80 |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | July 2006 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
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:
Contact: Carrie L. Dodrill, Ph.D. | 713-500-7079 | cdodrill@uth.tmc.edu |
Contact: Kirk von Sternberg, Ph.D. | 713-500-7577 | kvonsternberg@uth.tmc.edu |
United States, Texas | |
University of Texas Houston Mental Sciences Institute | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Angela L. Stotts, Ph.D. 713-500-2800 Angela.L.Stotts@uth.tmc.edu | |
Contact: Mary A Dhir 713-500-2874 Mary.A.Dhir@uth.tmc.edu | |
Principal Investigator: Mary M Velasquez, Ph.D. |
Principal Investigator: | Mary Marden Velasquez, Ph.D. | University of Texas Houston Medical School, Dept. of Family & Community Medicine |
Study ID Numbers: | 5-R01-DA015453-02, 5-R01-DA015453-02, UT CPHS ID - HSC-MS-02-138 |
Study First Received: | September 13, 2005 |
Last Updated: | February 1, 2006 |
ClinicalTrials.gov Identifier: | NCT00178776 |
Health Authority: | United States: Federal Government |
Group Therapy Cocaine Drugs Trial Outcome |
Study Feasibility Transtheoretical Stages Motivation Change |
Dopamine Mental Disorders Substance-Related Disorders Disorders of Environmental Origin Cocaine |
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Cardiovascular Agents |
Pharmacologic Actions Anesthetics, Local Sensory System Agents Therapeutic Uses Vasoconstrictor Agents Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |