Long Term Maintenance of Drug Abstinence

This study has been completed.
Sponsor:
Information provided by:
Treatment Research Institute
ClinicalTrials.gov Identifier:
NCT00842517
First received: October 24, 2007
Last updated: February 11, 2009
Last verified: February 2009
  Purpose

The purpose of this study is to develop a model for long-term maintenance of behavior change by examining the effects of extending the duration of contingency management (CM) for drug abuse on long-term abstinence outcomes. The primary hypothesis is that the Extended (36 week) CM group will have better long-term outcomes as exhibited by greater rates of abstinence at each follow-up assessment as compared to the Standard (12 week) CM group.


Condition Intervention Phase
Cocaine Dependence
Cocaine Abuse
Behavioral: Contingency Management
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Behavioral Model for Maintenance of Drug Abstinence

Further study details as provided by Treatment Research Institute:

Primary Outcome Measures:
  • Duration of cocaine abstinence [ Time Frame: Every 2 weeks for the first year the participant is involved in the study; in addition to 3 month, 6 month, 9 month, 12 month, 15 month, 18 month, 21 month, and 24 month assessment points. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The presence and frequency of non-drug using activities [ Time Frame: 3 month, 6 month, 9 month, 12 month, 15 month, 18 month, 21 month, 24 month ] [ Designated as safety issue: No ]
  • The presence and frequency of natural contingencies of reinforcement [ Time Frame: 3 month, 6 month, 9 month, 12 month, 15 month, 18 month, 21 month, 24 month ] [ Designated as safety issue: No ]
  • The presence and frequency of meaningful correlates of long-term behavior change [ Time Frame: Every 2 weeks for the first year the participant is involved in the study; in addition to 3 month, 6 month, 9 month, 12 month, 15 month, 18 month, 21 month, and 24 month assessment points. ] [ Designated as safety issue: No ]

Enrollment: 166
Study Start Date: September 2004
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Extended
36-week duration contingency management program
Behavioral: Contingency Management
Active Comparator: Standard
12-week duration contingency management program
Behavioral: Contingency Management

Detailed Description:

This protocol examines the effects of extending the duration of contingency management (CM) for drug abuse and dependence on long-term abstinence outcomes. Following the tenets of basic behavioral research, we have outlined a model for long-term behavior maintenance that suggests that successful long-term behavior change does not focus on undoing old behaviors, but concentrates on developing new behaviors in a wide variety of new contexts, and provides enduring reinforcement for the new behaviors. The implication of this model is that in order to develop strategies for supporting long-term behavior change we need to determine the optimal duration of continuing treatment-arranged contingencies, better specify incompatible behaviors that emerge for patients who are successful in sustaining periods of continuous drug abstinence, and determine which incompatible behaviors are most likely to have naturally-occurring sustaining contingencies of reinforcement. This research will examine the model by randomly assigning cocaine-dependent or cocaine-abusing methadone maintenance patients to either a Standard (12 week) or Extended (36 week) period of contrived contingencies. We will be conducting a 2 year follow-up in order to investigate whether providing a longer duration of CM will result in a greater proportion of abstinent individuals during this time, how long the abstinence will last and to discover if longer durations of drug abstinence during the first year after treatment entry will predict better longer-term abstinence outcomes. We also compare outcomes on abstinence-related behaviors to see if provision of an extended voucher program leads to an increase in non-drug using natural reinforcers and activities. This study participates in the NIH-sponsored Health Maintenance Consortium designed to promote interchange of concepts, methods and measures related to the maintenance of long-term behavior change.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meet DSM-IV criteria for current cocaine dependence or abuse
  • Be willing and able to give valid contact information
  • Be receiving a stable dose of 40 milligrams or more of methadone

Exclusion Criteria:

  • Are unable to give informed consent (fails simple open-ended consent quiz)
  • Answer yes to the question "Are you in recovery from gambling? That is, have you stopped gambling because of previous problems with gambling?"
  • Report that they have a romantic partner who is already participating in the study
  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: NCT00842517

Locations
United States, Pennsylvania
Parkside Recovery
Philadelphia, Pennsylvania, United States, 19131
Sponsors and Collaborators
Treatment Research Institute
Investigators
Principal Investigator: Kimberly C Kirby, Ph.D. Treatment Research Institute
  More Information

No publications provided

Responsible Party: Kimberly C. Kirby, Ph.D., Treatment Research Institute
ClinicalTrials.gov Identifier: NCT00842517     History of Changes
Other Study ID Numbers: 0308, R01DA017444
Study First Received: October 24, 2007
Last Updated: February 11, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Treatment Research Institute:
Cocaine Dependence
Cocaine Abuse
Substance Abuse
Contingency Management
Drug Treatment

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014