Vouchers vs. Prizes for Cocaine-Dependent Methadone Patients - 2

Cocaine Dependence Clinical Trial

Official title:

Vouchers vs. Prizes for Cocaine-Dependent Methadone Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00249535
• Other study ID #: NIDA-13444-2
• Secondary ID: R01DA013444
• Status: Completed
• Phase: N/A
• First received: November 3, 2005
• Last updated: March 29, 2012
• Start date: March 2005
• Est. completion date: July 2011

Study information

• Verified date: March 2012
• 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 compare voucher-based contingency management (CM) procedures to a lower-cost CM system that provides opportunities to win prizes. Cocaine-dependent outpatients are randomly assigned to (a) standard treatment, (b) standard treatment plus usual magnitude prize CM, (c) standard treatment plus higher magnitude prize CM, or (d) standard treatment plus voucher CM. Urine and breath samples are collected 2-3x/week for 14 weeks. Follow-up interviews are conducted at 1,3,6 and 9 months following intake during which substance use and psychosocial functioning are assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• age > 18 years

• current DSM-IV diagnosis of cocaine dependence

• received methadone treatment at the clinic for at least 3 months

• on a stable dose of methadone (no changes in dosing) for at least one month and not presently requesting a dose alteration

• submitted one or more clinic-collected cocaine positive urine samples in the previous 3 months

• English speaking

• pass a brief quiz related to understanding of the informed consent form

Exclusion criteria:

• have a serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, bipolar disorder, severe or psychotic major depression, or suicide risk)

• have dementia (<23 on the Mini Mental State Exam; Folstein et al. 1975)

• are in recovery from 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

• Cocaine Dependence

Intervention

Behavioral:
• Contingency management
Rewards (prizes) for abstinence

Locations

Country	Name	City	State
United States	UConn 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	Cocaine use		baseline and each follow-up	No