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

January 22, 2008
November 17, 2011
October 2003
April 2009   (final data collection date for primary outcome measure)
longest continuous period of cocaine abstinence [ Time Frame: baseline and at each follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00606853 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Enhanced and Attendance-based Prize CM in Community Settings
Enhanced and Attendance-based Prize CM in Community Settings

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Cocaine Dependence
Behavioral: Contingency Management
Rewards valued $1-$100 for abstinence or treatment attendance
  • 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.
    Intervention: Behavioral: Contingency Management
  • 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.
    Intervention: Behavioral: Contingency Management
  • 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.
    Intervention: Behavioral: Contingency Management
  • No Intervention: 4
    Standard Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
443
April 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00606853
04-008, P50DA009241, P50-DA09241
No
University of Connecticut Health Center
University of Connecticut Health Center
National Institute on Drug Abuse (NIDA)
Principal Investigator: Nancy M Petry, Ph.D. UConn Health Center
University of Connecticut Health Center
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP