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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dennis Donovan, University of Washington
ClinicalTrials.gov Identifier:
NCT00573183
First received: December 13, 2007
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Drug Abuse
Behavioral: STAGE-12
Behavioral: Treatment as Usual
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Days of Stimulant Use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of days of use of stimulant drugs within 30-day blocks across a 6-month post-baseline period


Secondary Outcome Measures:
  • Attendance at 12-step Meetings [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Days of attendance at 12-step meetings within 30-day blocks across a 6-month post-baseline period


Enrollment: 471
Study Start Date: January 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00573183

Locations
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
Investigators
Principal Investigator: Dennis Donovan, Ph.D. University of Washington
Principal Investigator: Dennis Daley, Ph.D. Western Psychiatric Institute and Clinic
  More Information

Additional Information:
Publications:
Responsible Party: Dennis Donovan, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00573183     History of Changes
Other Study ID Numbers: NIDA-CTN-0031, U10DA013714
Study First Received: December 13, 2007
Results First Received: June 4, 2013
Last Updated: January 28, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
Cocaine, methamphetamine, amphetamine, other stimulant drugs

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014