A Phase 1 interventional study of Transtheoretical Model Group Therapy and Education & Advice in Cocaine Use Disorders, sponsored by National Institute on Drug Abuse (NIDA). Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-01-11.
Sponsored by National Institute on Drug Abuse (NIDA) · Phase 1, Interventional, and Treatment
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.
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.
National Institute on Drug Abuse (NIDA) is the lead sponsor of 388 studies on the registry; 19 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
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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:
Behavioral: Transtheoretical Model Group Therapy
Behavioral: Education & Advice
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 Outcome Measures Related to Cocaine and other Drug Use:
1) Timeline Follow-Back (self-reported use / percent days
abstinent)
2) Cocaine Craving Worksheet (self report)
3) Cocaine Negative Consequences Checklist (self report)
4) Addiction Severity Index (ASI; Interviewer Administered)
5) Blood Alcohol Breath (biological)
6) Substance Use Report (self report)
Secondary Outcome Measures Related to Feasibility of the Group Therapy:
1) Participation / Attendance / Retention
2) MI Scale (Therapist Adherence)
3) Treatment Satisfaction Questionnaire
4) Group Therapy Alliance Scale
5) Group Atmosphere Scale
6) Therapist Treatment Evaluation
Secondary Outcome Measures Related to Psychiatric Symptoms:
1) Beck Depression Inventory (BDI-II)
2) Brief Symptom Inventory (BSI)
Secondary Outcomes Related to Functioning:
1) HIV Knowledge Questionnaire
2) Risk Behavior Assessment
3) SF-12
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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National Institute on Drug Abuse (NIDA)