Enhanced and Attendance-based Prize CM in Community Settings

NCT ID: NCT00606853

Last Updated: 2019-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 443 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2009-04-30

Brief 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.

Conditions

Cocaine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Standard Treatment plus prize contingency management for abstinence with an expected probability of winning about $250 in prizes and twice-weekly breath and urine samples.

Group Type: EXPERIMENTAL

Contingency Management

Intervention Type: BEHAVIORAL

Rewards valued $1-$100 for abstinence or treatment attendance

2

Standard Treatment plus prize contingency management for abstinence with an expected probability of winning about $560 in prizes and twice-weekly breath and urine samples.

Group Type: EXPERIMENTAL

Contingency Management

Intervention Type: BEHAVIORAL

Rewards valued $1-$100 for abstinence or treatment attendance

3

Standard Treatment plus prize contingency management for attendance with an expected probability of winning about $250 in prizes and twice-weekly breath and urine samples.

Group Type: EXPERIMENTAL

Contingency Management

Intervention Type: BEHAVIORAL

Rewards valued $1-$100 for abstinence or treatment attendance

4

Standard Treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Contingency Management

Rewards valued $1-$100 for abstinence or treatment attendance

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

UConn Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nancy M Petry, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UConn Health Center

Locations

UConn Health Center

Farmington, Connecticut, United States

Countries

United States

Other Identifiers

P50DA009241

Identifier Type: NIH

Identifier Source: secondary_id

View Link

04-008

Identifier Type: -

Identifier Source: org_study_id