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Addition of Naltrexone to Methadone Taper

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00135759
First received: August 23, 2005
Last updated: August 18, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention Phase
Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Drug: Naltrexone
Drug: Placebo comparator
Drug: naltrexone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Place of Low-Dose Naltrexone in Opiate Detoxification

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Withdrawal intensity [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Retention in treatment [ Time Frame: 6 days ] [ Designated as safety issue: No ]

Enrollment: 174
Study Start Date: April 2005
Study Completion Date: July 2006
Arms Assigned Interventions
Placebo Comparator: Group 1
Drug
Drug: Placebo comparator
1 capsule/day for 6 days
Experimental: 2
experimental
Drug: Naltrexone
low dose naltrexone in addition to daily methadone taper
Drug: naltrexone
0.125 mg capsule/day for 6 days
Experimental: 3
experimental
Drug: Naltrexone
low dose naltrexone in addition to daily methadone taper
Drug: naltrexone
0.250 mg capsule/day for 6 days

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135759

Locations
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27704
Sponsors and Collaborators
Investigators
Principal Investigator: Paolo Mannelli, M.D. Duke 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: Paolo Mannelli, M.D., Duke University
ClinicalTrials.gov Identifier: NCT00135759     History of Changes
Other Study ID Numbers: NIDA-15469-1, R21-15469-1, DPMC
Study First Received: August 23, 2005
Last Updated: August 18, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Disease
Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Pathologic Processes
Naltrexone
Central Nervous System Agents
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014