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Long Term Maintenance of Drug Abstinence

Primary Purpose

Cocaine Dependence, Cocaine Abuse

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Contingency Management
Sponsored by
Treatment Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring Cocaine Dependence, Cocaine Abuse, Substance Abuse, Contingency Management, Drug Treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Parkside Recovery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Extended

Standard

Arm Description

36-week duration contingency management program

12-week duration contingency management program

Outcomes

Primary Outcome Measures

Duration of cocaine abstinence

Secondary Outcome Measures

The presence and frequency of non-drug using activities
The presence and frequency of natural contingencies of reinforcement
The presence and frequency of meaningful correlates of long-term behavior change

Full Information

First Posted
October 24, 2007
Last Updated
March 27, 2023
Sponsor
Treatment Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00842517
Brief Title
Long Term Maintenance of Drug Abstinence
Official Title
A Behavioral Model for Maintenance of Drug Abstinence
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Treatment Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence, Cocaine Abuse
Keywords
Cocaine Dependence, Cocaine Abuse, Substance Abuse, Contingency Management, Drug Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extended
Arm Type
Experimental
Arm Description
36-week duration contingency management program
Arm Title
Standard
Arm Type
Active Comparator
Arm Description
12-week duration contingency management program
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly C Kirby, Ph.D.
Organizational Affiliation
Treatment Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkside Recovery
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19131
Country
United States

12. IPD Sharing Statement

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Long Term Maintenance of Drug Abstinence

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