NCT00135759

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2005

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

January 12, 2017

Status Verified

August 1, 2008

First QC Date

August 23, 2005

Last Update Submit

January 11, 2017

Conditions

Heroin DependenceOpioid-Related DisordersSubstance-Related Disorders

Keywords

opiate dependence

Outcome Measures

Primary Outcomes (1)

  • Withdrawal intensity

    6 days

Secondary Outcomes (1)

  • Retention in treatment

    6 days

Study Arms (3)

Group 1

PLACEBO COMPARATOR

Drug

Drug: Placebo comparator

2

EXPERIMENTAL

experimental

Drug: Naltrexone

3

EXPERIMENTAL

experimental

Drug: Naltrexone

Interventions

naltrexoneDRUG

low dose naltrexone in addition to daily methadone taper

23
Placebo comparatorDRUG

1 capsule/day for 6 days

Group 1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current DSM-IV diagnosis of opiate dependence
  • Reads and understands English

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27704, United States

Location

Related Publications (5)

  • 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.

    PMID: 23572466DERIVED

  • 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.

    PMID: 22233189DERIVED

  • 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.

    PMID: 21513688DERIVED

  • 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.

    PMID: 20631574DERIVED

  • 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.

    PMID: 19283561DERIVED

MeSH Terms

Conditions

Heroin DependenceOpioid-Related DisordersSubstance-Related Disorders

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Paolo Mannelli, M.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

August 23, 2005

First Posted

August 26, 2005

Study Start

April 1, 2005

Study Completion

July 1, 2006

Last Updated

January 12, 2017

Record last verified: 2008-08

Locations

US(1)