Cocaine Use Disorders Clinical Trial
Official title:
A Transtheoretical Model Group Therapy for Cocaine
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.
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). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Houston Mental Sciences Institute | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
National Institute on Drug Abuse (NIDA) | The University of Texas Health Science Center, Houston |
United States,
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.
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 |
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