Clinical trial NCT00135759: Addition of Naltrexone to Methadone Taper
Official title: Place of Low-Dose Naltrexone in Opiate Detoxification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Keywords: opiate dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2005-08-26
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is a continuing search for more effective opiate detoxification treatments. This study's purpose is to investigate the effects of adding very low doses of naltrexone to a methadone tapering treatment in opioid dependent individuals.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Withdrawal intensity
timeFrame: 6 days
Secondary outcomes:
measure: Retention in treatment
timeFrame: 6 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Paolo Mannelli, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.