Stimulant Abuser Groups to Engage in 12-Step (STAGE-12)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by National Institute on Drug Abuse (NIDA).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Washington
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00573183
First received: December 13, 2007
Last updated: November 16, 2009
Last verified: November 2009
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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 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 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 |
|---|---|
| Experimental: STAGE-12 |
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.
|
| No Intervention: Treatment as Usual |
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 | |
| 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
No publications provided
| Responsible Party: | Dennis Donovan, University of Washington |
| ClinicalTrials.gov Identifier: | NCT00573183 History of Changes |
| Other Study ID Numbers: | NIDA-CTN-0031, U10 DA13714 |
| Study First Received: | December 13, 2007 |
| Last Updated: | November 16, 2009 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013