Long Term Maintenance of Drug Abstinence

March 27, 2023 updated by: Treatment Research Institute

A Behavioral Model for Maintenance of Drug Abstinence

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

166

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19131
        • Parkside Recovery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Extended
36-week duration contingency management program
Behavioral: Contingency Management
Active Comparator: Standard
12-week duration contingency management program
Behavioral: Contingency Management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 month, 6 month, 9 month, 12 month, 15 month, 18 month, 21 month, 24 month
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
3 month, 6 month, 9 month, 12 month, 15 month, 18 month, 21 month, 24 month
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Treatment Research Institute

Investigators

  • Principal Investigator: Kimberly C Kirby, Ph.D., Treatment Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

October 24, 2007

First Submitted That Met QC Criteria

February 11, 2009

First Posted (Estimate)

February 12, 2009

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0308 (Klein Buendel, Inc.)
  • R01DA017444 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cocaine Dependence

Clinical Trials on Contingency Management

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe