- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00135759
Addition of Naltrexone to Methadone Taper
Place of Low-Dose Naltrexone in Opiate Detoxification
Study Overview
Status
Intervention / Treatment
Detailed Description
Although many different techniques for opiate detoxification exist, the search continues for more effective approaches to reduce the duration and discomfort associated with opioid withdrawal. It has been shown that very low doses of naltrexone administered in the presence of opiates has analgesic and dependency reducing properties. The purpose of this study is to investigate the effects of very low doses of naltrexone administered during a methadone tapering schedule for opiate detoxification. In addition, this study will compare the effectiveness of two different dose regimens of naltrexone.
Participants in this double-blind study will be recruited among opioid dependent individuals already enrolled in a 6-day inpatient opioid detoxification program. Participants will be already receiving standard treatment to control discomfort during a methadone tapering schedule. Participants will be randomly assigned to one of three groups. Two of the groups will be given naltrexone; Group 1 will receive 0.125 mg each day, and Group 2 will receive 0.250 mg each day. Group 3 will receive a placebo. Participants will be evaluated upon enrollment for opiate addiction severity. They will continue to be evaluated daily for signs of withdrawal and salivary cortisol. An additional evaluation and urine test will be completed 1 day following discharge. Daily evaluations will take 15 minutes to complete. Seven days following discharge, participants will be contacted for a 20-minute phone interview. During the phone interview, participants will schedule an appointment to provide a final urine specimen for the detection of drugs of abuse.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27704
- Duke University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Current DSM-IV diagnosis of opiate dependence
- Reads and understands English
Exclusion Criteria:
- Serious medical disorders (e.g., uncontrolled hypertension, acute or chronic active hepatitis, kidney failure, uncontrolled diabetes)
- Psychiatric conditions that require intensive services (e.g., depression with suicidal ideation, psychosis)
- Mental retardation or other disorder that might limit ability to give informed consent
- Pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Group 1
Drug
|
1 capsule/day for 6 days
|
EXPERIMENTAL: 2
experimental
|
low dose naltrexone in addition to daily methadone taper
|
EXPERIMENTAL: 3
experimental
|
low dose naltrexone in addition to daily methadone taper
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Withdrawal intensity
Time Frame: 6 days
|
6 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Retention in treatment
Time Frame: 6 days
|
6 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Paolo Mannelli, M.D., Duke University
Publications and helpful links
General Publications
- Mannelli P, Wu LT, Peindl KS, Gorelick DA. Smoking and opioid detoxification: behavioral changes and response to treatment. Nicotine Tob Res. 2013 Oct;15(10):1705-13. doi: 10.1093/ntr/ntt046. Epub 2013 Apr 9.
- Mannelli P, Peindl K, Wu LT, Patkar AA, Gorelick DA. The combination very low-dose naltrexone-clonidine in the management of opioid withdrawal. Am J Drug Alcohol Abuse. 2012 May;38(3):200-5. doi: 10.3109/00952990.2011.644003. Epub 2012 Jan 10.
- Mannelli P, Peindl K, Patkar AA, Wu LT, Tharwani HM, Gorelick DA. Problem drinking and low-dose naltrexone-assisted opioid detoxification. J Stud Alcohol Drugs. 2011 May;72(3):507-13. doi: 10.15288/jsad.2011.72.507.
- Mannelli P, Peindl K, Patkar AA, Wu LT, Pae CU, Gorelick DA. Reduced cannabis use after low-dose naltrexone addition to opioid detoxification. J Clin Psychopharmacol. 2010 Aug;30(4):476-8. doi: 10.1097/JCP.0b013e3181e5c168. No abstract available.
- Mannelli P, Patkar AA, Peindl K, Gottheil E, Wu LT, Gorelick DA. Early outcomes following low dose naltrexone enhancement of opioid detoxification. Am J Addict. 2009 Mar-Apr;18(2):109-16. doi: 10.1080/10550490902772785.
Study record dates
Study Major Dates
Study Start
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Pathologic Processes
- Narcotic-Related Disorders
- Substance-Related Disorders
- Disease
- Opioid-Related Disorders
- Heroin Dependence
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Sensory System Agents
- Narcotic Antagonists
- Alcohol Deterrents
- Naltrexone
Other Study ID Numbers
- NIDA-15469-1
- DPMC (Other Identifier: NIDA)
- R21-15469-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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