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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00573183
Recruitment Status : Completed
First Posted : December 14, 2007
Results First Posted : January 29, 2014
Last Update Posted : December 5, 2016
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Dennis Donovan, University of Washington

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Drug Abuse Behavioral: STAGE-12 Behavioral: Treatment as Usual Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 471 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00573183

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United States, Florida
Gateway Community Services
Jacksonville, Florida, United States, 32211
United States, Hawaii
Hina Mauka Kaneohe Rehabilitation Services
Kaneohe, Hawaii, United States, 96744
United States, Ohio
Maryhaven, Inc.
Columbus, Ohio, United States, 43207
United States, Oregon
Willamette Family Treatment Services
Eugene, Oregon, United States, 97402
ChangePoint, Inc.
Portland, Oregon, United States, 97233
United States, Pennsylvania
Addiction Medicine Services (WPIC)
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Dorchester Alcohol and Drug Commission
Summerville, South Carolina, United States, 29483
United States, Texas
Nexus Recovery Center
Dallas, Texas, United States, 75228
United States, Washington
Evergreen Manor, Inc.
Everett, Washington, United States, 98134
Recovery Centers of King County
Seattle, Washington, United States, 98122
Sponsors and Collaborators
University of Washington
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Dennis Donovan, Ph.D. University of Washington
Principal Investigator: Dennis Daley, Ph.D. Western Psychiatric Institute and Clinic
Additional Information:
Publications of Results:
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Responsible Party: Dennis Donovan, Professor, University of Washington Identifier: NCT00573183    
Other Study ID Numbers: NIDA-CTN-0031
U10DA013714 ( U.S. NIH Grant/Contract )
First Posted: December 14, 2007    Key Record Dates
Results First Posted: January 29, 2014
Last Update Posted: December 5, 2016
Last Verified: October 2016
Keywords provided by Dennis Donovan, University of Washington:
Cocaine, methamphetamine, amphetamine, other stimulant drugs
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders