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Addition of Naltrexone to Methadone Taper

Primary Purpose

Heroin Dependence, Opioid-Related Disorders, Substance-Related Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Naltrexone
Placebo comparator
naltrexone
naltrexone
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heroin Dependence focused on measuring opiate dependence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Group 1

2

3

Arm Description

Drug

experimental

experimental

Outcomes

Primary Outcome Measures

Withdrawal intensity

Secondary Outcome Measures

Retention in treatment

Full Information

First Posted
August 23, 2005
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00135759
Brief Title
Addition of Naltrexone to Methadone Taper
Official Title
Place of Low-Dose Naltrexone in Opiate Detoxification
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heroin Dependence, Opioid-Related Disorders, Substance-Related Disorders
Keywords
opiate dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Placebo Comparator
Arm Description
Drug
Arm Title
2
Arm Type
Experimental
Arm Description
experimental
Arm Title
3
Arm Type
Experimental
Arm Description
experimental
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Intervention Description
low dose naltrexone in addition to daily methadone taper
Intervention Type
Drug
Intervention Name(s)
Placebo comparator
Intervention Description
1 capsule/day for 6 days
Intervention Type
Drug
Intervention Name(s)
naltrexone
Intervention Description
0.125 mg capsule/day for 6 days
Intervention Type
Drug
Intervention Name(s)
naltrexone
Intervention Description
0.250 mg capsule/day for 6 days
Primary Outcome Measure Information:
Title
Withdrawal intensity
Time Frame
6 days
Secondary Outcome Measure Information:
Title
Retention in treatment
Time Frame
6 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Mannelli, M.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23572466
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.
Results Reference
derived
PubMed Identifier
22233189
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.
Results Reference
derived
PubMed Identifier
21513688
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.
Results Reference
derived
PubMed Identifier
20631574
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.
Results Reference
derived
PubMed Identifier
19283561
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.
Results Reference
derived

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Addition of Naltrexone to Methadone Taper

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