A Transtheoretical Model Group Therapy for Cocaine

Cocaine Use Disorders Clinical Trial

Official title:

A Transtheoretical Model Group Therapy for Cocaine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00178776
• Other study ID #: 5R01DA015453-02
• Secondary ID: R01DA015453-02UT
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2005
• Last updated: January 10, 2017
• Start date: October 2003
• Est. completion date: June 2007

Study information

• Verified date: September 2014
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: June 2007
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine Use Disorders

Intervention

Behavioral:
• Transtheoretical Model Group Therapy

• Education & Advice

Locations

Country	Name	City	State
United States	University of Texas Houston Mental Sciences Institute	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)	The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Secondary Outcome Measures Related to Cocaine and other Drug Use:
Secondary	1) Timeline Follow-Back (self-reported use / percent days
Secondary	abstinent)
Secondary	2) Cocaine Craving Worksheet (self report)
Secondary	3) Cocaine Negative Consequences Checklist (self report)
Secondary	4) Addiction Severity Index (ASI; Interviewer Administered)
Secondary	5) Blood Alcohol Breath (biological)
Secondary	6) Substance Use Report (self report)
Secondary	Secondary Outcome Measures Related to Feasibility of the Group Therapy:
Secondary	1) Participation / Attendance / Retention
Secondary	2) MI Scale (Therapist Adherence)
Secondary	3) Treatment Satisfaction Questionnaire
Secondary	4) Group Therapy Alliance Scale
Secondary	5) Group Atmosphere Scale
Secondary	6) Therapist Treatment Evaluation
Secondary	Secondary Outcome Measures Related to Psychiatric Symptoms:
Secondary	1) Beck Depression Inventory (BDI-II)
Secondary	2) Brief Symptom Inventory (BSI)
Secondary	Secondary Outcomes Related to Functioning:
Secondary	1) HIV Knowledge Questionnaire
Secondary	2) Risk Behavior Assessment
Secondary	3) SF-12