Phase 2
N=35
Employment-Based Depot Naltrexone Clinical Trial
Opiate Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00684788 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Percentage of Depot Naltrexone Doses Received — 42.2; 80.6 percentage of injections — p==0.008
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- employment-based reinforcement (Combination_product)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Depot Naltrexone Doses Received |
42.2; 80.6 | =0.008 sig |
| SECONDARY The Time to the First Missed Dose of Depot Naltrexone |
9.3; 15.5 | 0.0033 sig |
| SECONDARY Percentage of 30-day Assessments Urine Samples Negative for Opiates |
61.8; 73.6 | — |
| SECONDARY Percentage of Monday, Wednesday, Friday Urine Samples Negative for Opiates |
51.6; 72.0 | — |
| SECONDARY Percentage of 30-day Assessments Urine Samples Negative for Cocaine |
54.4; 55.6 | 0.939 |
| SECONDARY Percentage of Monday, Wednesday, Friday Urine Samples Negative for Cocaine |
48.9; 55.6 | — |
| SECONDARY HIV Risk Behaviors |
5; 5 | 0.959 |
Summary
The purpose of this study is to determine whether employment-based naltrexone treatment proves effective in promoting depot naltrexone adherence and drug abstinence.
Eligibility Criteria
Individuals were eligible if they:
- met the Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition (DSM-IV) criteria for opioid dependence,
- reported using heroin on at least 21 of the last 30 days while in community,
- were unemployed,
- were aged 18-65 years,
- were medically approved for naltrexone
- lived in or near Baltimore, MD.
Individuals were excluded if they
- had current DSM-IV major Axis I disorders,
- had current suicidal or homicidal ideation,
- expressed interest in methadone treatment,
- were required to use opioids for medical purposes,
- earned more than $200 in taxable income over the previous 30 days,
- had physical limitations that would prevent them from using a keyboard,
- were pregnant or breastfeeding,
- had serum aminotransferase levels more than three times over normal.
Data sourced from ClinicalTrials.gov (NCT00684788). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.