Stimulant Abuser Groups to Engage in 12-Step - Full Text View

Sponsor:	University of Washington
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00573183

Purpose

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

Condition	Intervention	Phase
Stimulant Abuse or Dependence	Behavioral: Twelve Step Facilitation (TSF)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
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 National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Reduction in percent of days of stimulant use [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Increased attendance at 12-step meetings [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
STAGE-12: Experimental	Behavioral: Twelve Step Facilitation (TSF) 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.
Treatment as Usual: No Intervention

Arms

Assigned Interventions

STAGE-12: Experimental

Behavioral: Twelve Step Facilitation (TSF)

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.

Treatment as Usual: No Intervention

Detailed Description:

This protocol is to evaluate the degree to which a combined group and individual 12-Step facilitative 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
ChangePoint, Inc.
Portland, Oregon, United States, 97233
Willamette Family Treatment Services
Eugene, Oregon, United States, 97402
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
Recovery Centers of King County
Seattle, Washington, United States, 98122
Evergreen Manor, Inc.
Everett, Washington, United States, 98134

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

No publications provided

Responsible Party:	University of Washington ( Dennis Donovan )
Study ID Numbers:	NIDA-CTN-0031, U10 DA13714
Study First Received:	December 13, 2007
Last Updated:	November 16, 2009
ClinicalTrials.gov Identifier:	NCT00573183 History of Changes
Health Authority:	United States: Federal Government

ClinicalTrials.gov processed this record on February 08, 2010