Drug AbusePhase 3STAGE-12NCT00573183

Stimulant Abuser Groups to Engage in 12-Step

A Phase 3 study testing STAGE-12 and Treatment as Usual in people with Drug Abuse, run by University of Washington at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Drug Abuse
What is being tested?: STAGE-12 and Treatment as Usual
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 471 participants
Where: 10 sitesUnited States
Study dates: Jan 2008to Apr 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

seeking outpatient treatment for stimulant abuse or dependence
current diagnosis of stimulant abuse or dependence
willing to participate in the protocol

Who cannot join

not sufficiently medically or psychiatrically stable
pending legal action that would inhibit their participation in the study
in need of detoxification from opiates

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Maryhaven, Inc.
Columbus, Ohio, 43207
Nexus Recovery Center
Dallas, Texas, 75228
Willamette Family Treatment Services
Eugene, Oregon, 97402
Evergreen Manor, Inc.
Everett, Washington, 98134
Gateway Community Services
Jacksonville, Florida, 32211
Hina Mauka Kaneohe Rehabilitation Services
Kaneohe, Hawaii, 96744
Addiction Medicine Services (WPIC)
Pittsburgh, Pennsylvania, 15213
ChangePoint, Inc.
Portland, Oregon, 97233
Recovery Centers of King County
Seattle, Washington, 98122
Dorchester Alcohol and Drug Commission
Summerville, South Carolina, 29483

Other trials in United States

About this 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

Read the 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.

Conditions: Drug Abuse
Being tested: STAGE-12, Treatment as Usual
Keywords: Cocaine, methamphetamine, amphetamine, other stimulant drugs
Medical subject headings: Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

STAGE-12Behavioural
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 UsualBehavioural

Study groups in NCT00573183
Study group	Role	What they receive
STAGE-12	Experimental	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. Receives: Behavioral: STAGE-12
Treatment as Usual	Active comparator	Treatment as usual received standard care provided in intensive outpatient drug treatment program without the STAGE-12 components. Receives: Behavioral: Treatment as Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

Days of Stimulant Use
Number of days of use of stimulant drugs within 30-day blocks across a 6-month post-baseline period
Measured: 6 months

Secondary outcomes (1)

Attendance at 12-step Meetings
Days of attendance at 12-step meetings within 30-day blocks across a 6-month post-baseline period
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Apr 2010

First posted14 Dec 2007 (estimated)
Study startJan 2008
Primary completionApr 2010
Study completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Drug AbuseStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 471 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00573183
Sponsor's protocol ID: NIDA-CTN-0031
Other IDs: U10DA013714
Acronym: STAGE-12
Status last verified: Oct 2016
First submitted: 13 Dec 2007
Last updated: 5 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 22657748

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00573183
Acronym / sponsor ID: STAGE-12 / NIDA-CTN-0031
Conditions: Drug Abuse
Keywords: Cocaine, methamphetamine, amphetamine, other stimulant drugs
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 471 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Jan 2008
Primary completion: Apr 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 14 Dec 2007 (estimated)
Results: Posted 29 Jan 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
STAGE-12	Experimental	Behavioral: STAGE-12STAGE-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.
Treatment as Usual	Active comparator	Behavioral: Treatment as UsualTreatment as usual received standard care provided in intensive outpatient drug treatment program without the STAGE-12 components.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

seeking outpatient treatment for stimulant abuse or dependence
current diagnosis of stimulant abuse or dependence
willing to participate in the protocol

Key exclusion criteria (3 listed)

not sufficiently medically or psychiatrically stable
pending legal action that would inhibit their participation in the study
in need of detoxification from opiates

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
STAGE-12The 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.	Behavioural	STAGE-12
Treatment as Usual	Behavioural	Treatment as Usual

Primary outcome

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

1 secondary outcome

Attendance at 12-step Meetings
Time frame: 6 months

Results and safety

Results posted to the registry on 29 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
STAGE-12	234	162
Treatment as Usual	237	174

Primary outcome: Days of Stimulant Use

Time frame: 6 months. Mean (Standard Deviation). Unit: days of stimulant use

Measure	Treatment as Usual n = 217	STAGE-12 n = 204
Value	2.35 (5.39)	2.13 (4.32)

Treatment as Usual vs STAGE-12: Odds Ratio (OR): 3.3404 (95% CI 1.2019 to 9.2842), p <0.05, Mixed Models Analysis
Treatment as Usual vs STAGE-12: Odds Ratio (OR): 2.4373 (95% CI 1.0131 to 5.8637), p <0.01, Mixed Models Analysis

Population analysed: The original sample size was based on power analysis and took attrition into account. Of the 471 individuals randomized to treatment, 50 subjects (TAU, n=20, STAGE-12, n=30) did not have any post-baseline measures and were therefore eliminated from the statistical analysis of the primary outcome and some of the secondary outcomes.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
STAGE-12	29 of 234 (12.4%)	10 of 234 (4.3%)	Not reported
Treatment as Usual	23 of 237 (9.7%)	15 of 237 (6.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22657748Donovan 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.
Link to description of the STAGE-12 protocol on the NIDA Clinical Trials Network web siteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dennis Donovan, Ph.D. principal investigator

University of Washington

Dennis Daley, Ph.D. principal investigator

Western Psychiatric Institute and Clinic

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing STAGE-12 and Treatment as Usual in people with Drug Abuse, run by University of Washington at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Days of Stimulant Use (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00573183, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2016.