Stimulant Abuser Groups to Engage in 12-Step (STAGE-12)

October 24, 2016 updated by: Dennis Donovan, University of Washington

Stimulant Abuser Groups to Engage in 12-Step (STAGE-12): Evaluation of a Combined Individual-Group Intervention to Reduce Stimulant and Other Drug Use by Increasing 12-Step Involvement

The purpose of this study is to determine whether a combined group and individual 12-Step facilitative (TSF) intervention, Stimulant Abuser Groups to Engage in 12 -Step (STAGE-12), improves substance -related outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This protocol is to evaluate the degree to which a combined group and individual 12-Step facilitative (TSF) intervention, Stimulant Abuser Groups to Engage in 12 -Step (STAGE-12), improves substance -related outcomes compared to treatment as usual (TAU) without STAGE-12 among stimulant abusers. The primary objective is to evaluate reduction in percent of days of stimulant use as measured by self-report. Secondary objectives include evaluating reduction in percent days of use of other substances, the degree to which STAGE-12 increases involvement in 12-step activities and attendance at 12-step meetings, and the extent to which such 12 -step involvement and meeting attendance mediate substance use outcomes.

Study Type

Interventional

Enrollment (Actual)

471

Phase

  • Phase 3

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
    • Florida
      • Jacksonville, Florida, United States, 32211
        • Gateway Community Services
    • Hawaii
      • Kaneohe, Hawaii, United States, 96744
        • Hina Mauka Kaneohe Rehabilitation Services
    • Ohio
      • Columbus, Ohio, United States, 43207
        • Maryhaven, Inc.
    • Oregon
      • Eugene, Oregon, United States, 97402
        • Willamette Family Treatment Services
      • Portland, Oregon, United States, 97233
        • ChangePoint, Inc.
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Addiction Medicine Services (WPIC)
    • South Carolina
      • Summerville, South Carolina, United States, 29483
        • Dorchester Alcohol and Drug Commission
    • Texas
      • Dallas, Texas, United States, 75228
        • Nexus Recovery Center
    • Washington
      • Everett, Washington, United States, 98134
        • Evergreen Manor, Inc.
      • Seattle, Washington, United States, 98122
        • Recovery Centers of King County

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:

  • seeking outpatient treatment for stimulant abuse or dependence
  • current diagnosis of stimulant abuse or dependence
  • willing to participate in the protocol

Exclusion Criteria:

  • not sufficiently medically or psychiatrically stable
  • pending legal action that would inhibit their participation in the study
  • in need of detoxification from opiates

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: STAGE-12
STAGE-12 received 3 individual and 5 group 12-step facilitation sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions in the standard intensive outpatient drug treatment program and were integrated into treatment as usual.
Behavioral: STAGE-12
The STAGE-12 intervention will consist of a combination of five group and three individual sessions. The five group sessions will be taken from the Project MATCH Twelve Step Facilitation manual as modified for use with drug abusers and adapted for delivery in a group format. The group sessions will be augmented by three individual sessions derived from the introductory and termination sessions from the TSF manual and incorporating elements of the brief intensive 12-step referral procedure.
Active Comparator: Treatment as Usual
Treatment as usual received standard care provided in intensive outpatient drug treatment program without the STAGE-12 components.
Behavioral: Treatment as Usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days of Stimulant Use
Time Frame: 6 months
Number of days of use of stimulant drugs within 30-day blocks across a 6-month post-baseline period
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attendance at 12-step Meetings
Time Frame: 6 months
Days of attendance at 12-step meetings within 30-day blocks across a 6-month post-baseline period
6 months

Collaborators and Investigators

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

Sponsor

University of Washington

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Dennis Donovan, Ph.D., University of Washington
  • Principal Investigator: Dennis Daley, Ph.D., Western Psychiatric Institute And Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

December 13, 2007

First Submitted That Met QC Criteria

December 13, 2007

First Posted (Estimate)

December 14, 2007

Study Record Updates

Last Update Posted (Estimate)

December 5, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-CTN-0031
  • U10DA013714 (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.

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