Drug Abuse
Conditions
Keywords
Cocaine, methamphetamine, amphetamine, other stimulant drugs
Brief 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.
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.
Interventions
BEHAVIORALSTAGE-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.
BEHAVIORALTreatment as Usual
Sponsors
National Institute on Drug Abuse (NIDA)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days of Stimulant Use | 6 months | Number of days of use of stimulant drugs within 30-day blocks across a 6-month post-baseline period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Attendance at 12-step Meetings | 6 months | Days of attendance at 12-step meetings within 30-day blocks across a 6-month post-baseline period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| STAGE-12 Received 3 individual and 5 group 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. | 234 |
| Treatment as Usual Received standard care provided in intensive outpatient drug treatment program | 237 |
| Total | 471 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Death | 0 | 1 |
| Overall Study | Incarceration | 5 | 8 |
| Overall Study | Lost to Follow-up | 52 | 50 |
| Overall Study | Other | 5 | 2 |
| Overall Study | Withdrawal by Subject | 8 | 2 |
Baseline characteristics
| Characteristic | Treatment as Usual | STAGE-12 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 237 Participants | 234 Participants | 471 Participants |
| Age, Continuous | 38.45 years STANDARD_DEVIATION 9.4 | 38.24 years STANDARD_DEVIATION 10.04 | 38.35 years STANDARD_DEVIATION 9.71 |
| Gender Female | 132 Participants | 145 Participants | 277 Participants |
| Gender Male | 105 Participants | 89 Participants | 194 Participants |
| Region of Enrollment United States | 237 participants | 234 participants | 471 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 234 | 15 / 237 |
| serious Total, serious adverse events | 29 / 234 | 23 / 237 |
Outcome results
Primary
Days of Stimulant Use
Number of days of use of stimulant drugs within 30-day blocks across a 6-month post-baseline period
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual | Days of Stimulant Use | 2.35 days of stimulant use | Standard Deviation 5.39 |
| STAGE-12 | Days of Stimulant Use | 2.13 days of stimulant use | Standard Deviation 4.32 |
Comparison: Mixture model with a logistic part for assessing zero-inflation and a negative binomial part for the over-dispersed count data, with corresponding 95% confidence intervals (CIs) of the odds ratios for logistic part and incidence rate ratios for negative binomial part.p-value: <0.0595% CI: [1.2019, 9.2842]Mixed Models Analysis
p-value: <0.0195% CI: [1.0131, 5.8637]Mixed Models Analysis
Secondary
Attendance at 12-step Meetings
Days of attendance at 12-step meetings within 30-day blocks across a 6-month post-baseline period
Time frame: 6 months
Population: The sample size was originally powered based on the primary outcome measure, not on the secondary 12-step measures.The analysis sample size was reduced due to missing values
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual | Attendance at 12-step Meetings | 12.01 days of attending 12-step meetings | Standard Deviation 9.73 |
| STAGE-12 | Attendance at 12-step Meetings | 10.52 days of attending 12-step meetings | Standard Deviation 9.87 |
Comparison: Outcome measure: Number of days of self-reported Self-Help meeting attendance by the Substance Use Calendar (SUC) within a 30-day window of assessment at mid-treatment, end-of-treatment, first, second, third and last follow-upsp-value: <0.05Zero-inflated negative binomial random-e