Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Transtheoretical Model Group Therapy for Cocaine

This study has been completed.
Sponsor:
Collaborator:
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Mary Marden Velasquez, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00178776
First received: September 13, 2005
Last updated: September 29, 2014
Last verified: September 2014
  Purpose

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 Phase
Cocaine Use Disorders
Behavioral: Transtheoretical Model Group Therapy
Behavioral: Education & Advice
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Transtheoretical Model Group Therapy for Cocaine

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 138
Study Start Date: October 2003
Study Completion Date: June 2007
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transtheoretical Model Group Behavioral: Transtheoretical Model Group Therapy
Active Comparator: Education / Advice Behavioral: Education & Advice

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178776

Locations
United States, Texas
University of Texas Houston Mental Sciences Institute
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Mary Marden Velasquez, Ph.D. University of Texas Houston Medical School, Dept. of Family & Community Medicine
  More Information

Publications:
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.

Responsible Party: Mary Marden Velasquez, Professor, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00178776     History of Changes
Other Study ID Numbers: 5-R01-DA015453-02, R01DA015453-02, UT CPHS ID - HSC-MS-02-138
Study First Received: September 13, 2005
Last Updated: September 29, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
Group
Therapy
Cocaine
Drugs
Trial
Outcome
Study
Feasibility
Transtheoretical
Stages
Motivation
Change

ClinicalTrials.gov processed this record on March 03, 2015