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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00249418
Other study ID # NIDA-16855-3
Secondary ID R01DA016855
Status Completed
Phase N/A
First received November 3, 2005
Last updated November 17, 2011
Start date January 2004
Est. completion date September 2009

Study information

Verified date November 2011
Source University of Connecticut Health Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to train therapists to administer contingency management (CM). This project will train up to 42 community-based treatment providers about the rationale for and the specifics of administering CM. Initial training will occur in 2-day workshops, followed by weekly supervision in delivery of CM with test cases. We expect that the majority of therapists will achieve high levels of competence and adherence in administering CM treatment within 3-5 test cases, as measured by ratings of audiotapes. To examine the efficacy of CM, each therapist who achieves adherence and competence in delivering CM will administer standard treatment alone or standard treatment plus CM to substance-abusing outpatients. In the CM condition, patients will have the opportunity to win prizes for submission of negative samples, and the treatment will be in effect for 12 weeks. In total, up to 200 patients will be randomly assigned to one of the two conditions. A research evaluator will conduct follow-up assessments, scheduled for 3, 6 and 9 months after treatment initiation.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

- age 18 years or older

- meets DSM-IV criteria for cocaine abuse or dependence

- English speaking (est. >90% of patients)

For those in drug-free programs, they must have initiated treatment within the past week. For methadone patients, they must be stabilized on a dose of methadone, defined as being on the same dose for at least 30 days and not currently requesting or being considered for a dose modification. Methadone patients must also have submitted at least 30% cocaine positive urine samples in the past 3 months.

Exclusion criteria:

- acute uncontrolled psychiatric disorder (psychosis, suicidality) as determined by the SCID

- dementia (<23 on the Mini Mental State Exam; Folstein & Folstein, 1975)

- in recovery for pathological gambling

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Contingency management
Rewards (prizes) for abstinence

Locations

Country Name City State
United States University of Connecticut Health Center Farmington Connecticut

Sponsors (2)

Lead Sponsor Collaborator
University of Connecticut Health Center National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Drug use baseline and each follow-up No
Primary Retention each follow-up No
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