Employment-Based Depot Naltrexone Clinical Trial
Recruitment status was Recruiting
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Purpose
The purpose of this study is to determine whether employment-based naltrexone treatment proves effective in promoting depot naltrexone adherence and drug abstinence.
| Condition | Intervention | Phase |
|---|---|---|
|
Opiate Dependence |
Behavioral: Contingency management |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Employment-Based Depot Naltrexone Clinical Trial |
- The number of depot naltrexone doses that participants received
- The time to the first missed dose of depot naltrexone
- Percentage of urine samples collected at the 30-day assessments that are positive for opiates
- Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are positive for opiates
- Percentage of urine samples collected at the 30-day assessments that are positive for cocaine
- Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are positive for cocaine
- HIV risk behaviors
| Estimated Enrollment: | 80 |
| Study Start Date: | May 2006 |
A randomized study is planned over 5 years to evaluate the effectiveness of the Therapeutic Workplace in promoting naltrexone adherence in opiate-dependent adults. An extended-release depot formulation of naltrexone will be used. Participants will be offered an inpatient opioid detoxification and naltrexone induction. Participants who complete the oral naltrexone induction (N=80) will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Patients in the "Work Plus Naltrexone Contingency" condition will earn access to working and earning salary by taking depot naltrexone once per month. "Work Plus Naltrexone Prescription" participants will be encouraged to take depot naltrexone monthly, but access to working and earning salary will not be contingent on doing so.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Applicants that are patients in the Chemical Dependency Unit, Addiction Treatment Services, or the Behavioral Pharmacology Research Unit may be eligible for this study.
Applicants will be blind to the full details of the eligibility criteria.
Contacts and Locations| Contact: Karly Diemer, MA | 410-550-6723 | kdiemer@jhmi.edu |
| Contact: Kylene Broadwater, BS | 410-550-4943 | kbroadwater@jhmi.edu |
| United States, Maryland | |
| The Center for Learning and Health | Recruiting |
| Baltimore, Maryland, United States, 21224 | |
| Principal Investigator: | Kenneth Silverman, Ph.D. | Johns Hopkins University |
More Information
No publications provided by National Institute on Drug Abuse (NIDA)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Cecilia McNamara Spitznas, Ph.D., NIDA |
| ClinicalTrials.gov Identifier: | NCT00684788 History of Changes |
| Other Study ID Numbers: | NIDA-19497-1, R01-19497-1 |
| Study First Received: | May 23, 2008 |
| Last Updated: | May 23, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Institute on Drug Abuse (NIDA):
|
opiate dependence naltrexone reinforcement |
behavior therapy cocaine dependence risk reduction behavior |
Additional relevant MeSH terms:
|
Opioid-Related Disorders Substance-Related Disorders Mental Disorders Naltrexone Narcotic Antagonists Physiological Effects of Drugs |
Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013