Enhanced and Attendance-based Prize CM in Community Settings

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00606853
First received: January 22, 2008
Last updated: November 17, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Cocaine Dependence
Behavioral: Contingency Management
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Enhanced and Attendance-based Prize CM in Community Settings

Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • longest continuous period of cocaine abstinence [ Time Frame: baseline and at each follow-up ] [ Designated as safety issue: No ]

Enrollment: 443
Study Start Date: October 2003
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: Contingency Management
Rewards valued $1-$100 for abstinence or treatment attendance
Experimental: 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.
Behavioral: Contingency Management
Rewards valued $1-$100 for abstinence or treatment attendance
Experimental: 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.
Behavioral: Contingency Management
Rewards valued $1-$100 for abstinence or treatment attendance
No Intervention: 4
Standard Treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606853

Locations
United States, Connecticut
UConn Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
Principal Investigator: Nancy M Petry, Ph.D. UConn Health Center
  More Information

No publications provided

Responsible Party: University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT00606853     History of Changes
Other Study ID Numbers: 04-008, P50DA009241, P50-DA09241
Study First Received: January 22, 2008
Last Updated: November 17, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:
Substance abuse
Contingency Management

ClinicalTrials.gov processed this record on October 29, 2014