Phase 2
N=38
Employment-Based Depot Naltrexone Clinical Trial II
Opiate Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00684775 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Naltrexone Injections Received — 51.8; 86.8 Percentage of injections received — p==0.002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Work Plus Naltrexone Contingency (Combination_product)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Naltrexone Injections Received |
51.8; 86.8 | =0.002 sig |
| PRIMARY Time to the First Missed Dose |
14.74; 20.84 | 0.0081 sig |
| SECONDARY Percentage of 30-day Urine Samples Negative for Opiates |
65.3; 71.6 | 0.56 |
| SECONDARY Percentage of M-W-F Samples Negative for Cocaine |
45.3; 54.6 | =0.41 |
| SECONDARY Average Percentage of 30-day Urine Samples Negative for Cocaine |
53.7; 57.9 | 0.75 |
| SECONDARY HIV Risk Behaviors |
2.1; 0 | 0.1543 |
| SECONDARY Percentage of M,W,F Urine Samples Negative for Opiates |
51.8; 66.2 | 0.15 |
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 (DSM)-IV criteria for opioid dependence,
- reported using heroin at least 21 of the last 30 days while living in the community,
- were unemployed,
- were 18-65 years old,
- were medically approved for naltrexone,
- lived in or near Baltimore, MD.
Individuals were excluded if they:
- were pregnant or breastfeeding,
- had serum aminotransferase levels over three times normal,
- had current hallucinations, delusions, or thought disorders, current suicidal or -homicidal ideation,
- expressed interest in methadone treatment,
- were required to use opioids for medical purposes,
- earned over $200 in taxable income over the previous 30 days,
- had physical limitations that would prevent them from using a keyboard, or were incarcerated or under constant monitoring by the criminal justice system.
Data sourced from ClinicalTrials.gov (NCT00684775). 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.