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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00573183
First Posted: December 14, 2007
Last Update Posted: December 5, 2016
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.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Dennis Donovan, University of Washington
December 13, 2007
December 14, 2007
June 4, 2013
January 29, 2014
December 5, 2016
January 2008
April 2010   (Final data collection date for primary outcome measure)
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
Reduction in percent of days of stimulant use [ Time Frame: 6 months ]
Complete list of historical versions of study NCT00573183 on ClinicalTrials.gov Archive Site
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
Increased attendance at 12-step meetings [ Time Frame: 6 months ]
Not Provided
Not Provided
 
Stimulant Abuser Groups to Engage in 12-Step
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug Abuse
  • 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.
  • Behavioral: Treatment as Usual
  • 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.
    Intervention: Behavioral: STAGE-12
  • Active Comparator: Treatment as Usual
    Treatment as usual received standard care provided in intensive outpatient drug treatment program without the STAGE-12 components.
    Intervention: Behavioral: Treatment as Usual
Donovan DM, Daley DC, Brigham GS, Hodgkins CC, Perl HI, Garrett SB, Doyle SR, Floyd AS, Knox PC, Botero C, Kelly TM, Killeen TK, Hayes C, Kau'i Baumhofer N, Seamans C, Zammarelli L. Stimulant abuser groups to engage in 12-step: a multisite trial in the National Institute on Drug Abuse Clinical Trials Network. J Subst Abuse Treat. 2013 Jan;44(1):103-14. doi: 10.1016/j.jsat.2012.04.004. Epub 2012 May 31. Erratum in: J Subst Abuse Treat. 2015 Feb;49:71. Kau'ibaumhofer, Nicole [corrected to Kau'i Baumhofer, Nicole].

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
471
April 2010
April 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00573183
NIDA-CTN-0031
U10DA013714 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Dennis Donovan, University of Washington
University of Washington
National Institute on Drug Abuse (NIDA)
Principal Investigator: Dennis Donovan, Ph.D. University of Washington
Principal Investigator: Dennis Daley, Ph.D. Western Psychiatric Institute and Clinic
University of Washington
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP