Addition of Naltrexone to Methadone Taper

Substance-Related Disorders Clinical Trial

Official title:

Place of Low-Dose Naltrexone in Opiate Detoxification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00135759
• Other study ID #: NIDA-15469-1
• Secondary ID: R21-15469-1DPMC
• Status: Completed
• Phase: Phase 2
• First received: August 23, 2005
• Last updated: January 11, 2017
• Start date: April 2005
• Est. completion date: July 2006

Study information

• Verified date: August 2008
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Heroin Dependence
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

Drug:
• Naltrexone
low dose naltrexone in addition to daily methadone taper
• Placebo comparator
1 capsule/day for 6 days
• naltrexone
0.125 mg capsule/day for 6 days
• naltrexone
0.250 mg capsule/day for 6 days

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Withdrawal intensity		6 days	Yes
Secondary	Retention in treatment		6 days	No