Enhanced and Attendance-based Prize CM in Community Settings

Cocaine Dependence Clinical Trial

Official title:

Enhanced and Attendance-based Prize CM in Community Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00606853
• Other study ID #: 04-008
• Secondary ID: P50DA009241
• Status: Completed
• Phase: N/A
• Start date: October 2003
• Est. completion date: April 2009

Study information

• Verified date: April 2019
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to address the conditions under which prize contingency management (CM) for abstinence and attendance may improve outcomes of cocaine-dependent patients.

For patients who initiate treatment with a cocaine-positive urine specimen, we will evaluate the efficacy of two CM procedures relative to standard, non-CM treatment. The two CM procedures will be provided as additions to standard care and will reinforce drug abstinence but will differ in expected magnitudes of prizes patients can earn, especially during early stages of abstinence. They will provide expected magnitudes of winning about $250 and $560, respectively. We expect that both CM conditions will improve retention and abstinence relative to the standard treatment, non-CM condition. If the enhanced CM condition engenders better outcomes than the $250 CM condition, this finding would suggest that patients initiating treatment while actively using cocaine may best be treated with relatively high reinforcement prize CM as an adjunct to standard care.

For patients who initiate treatment with a cocaine-negative urine specimen, we will evaluate the efficacy of a CM procedure that reinforces treatment attendance. The expected magnitude of winnings will be about $250, and again CM treatment will be in addition to standard care. This CM condition will be compared to standard treatment without CM as well as to a CM treatment that provides a similar magnitude of reinforcement, but contingent upon abstinence. Results from this study will inform an important clinical question of whether simply reinforcing attendance can improve clinical outcomes. Increased retention may result in greater exposure to therapeutic processes that may reduce drug use, especially among patients who begin treatment having already achieved some abstinence. We will also evaluate the cost-effectiveness of CM by examining the effects of the interventions on hospitalizations, medical and psychiatric care, criminal justice costs, and productivity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 443
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Current DSM-IV diagnosis of cocaine dependence

• A cocaine-positive urine sample submitted during the first two scheduled treatment days at the center

• Willing to provide names, addresses and phone numbers of individuals to assist in locating the patient for follow-up evaluations

• English speaking

• Willing to sign informed consent.

Exclusion Criteria:

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

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

• In recovery from pathological gambling

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Behavioral:
• Contingency Management
Rewards valued $1-$100 for abstinence or treatment attendance

Locations

Country	Name	City	State
United States	UConn Health Center	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
UConn Health	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	longest continuous period of cocaine abstinence		baseline and at each follow-up