A randomised, controlled trial of low dose naltrexone for the treatment of opioid dependence.

Abstract

AIM:

To investigate the efficacy of low doses of naltrexone in relapse prevention for heroin dependence.

DESIGN:

Double blind, randomised comparison of three groups-Group 1 taking 50mg per day, Group 2: 0.5mg per day, and Group 3: 0.05 mg per day.

PARTICIPANTS:

Sixty-six dependent heroin users.

INTERVENTIONS:

After detoxification followed by 1 week on 50mg per day naltrexone, participants were randomised to trial medication. All were offered counselling and monitored with weekly clinical reviews. Research interviews were conducted at three and 6 months.

OUTCOME MEASURES:

Retention in treatment and heroin use at 3 and 6 months. Secondary outcome measures were side effects and craving.

FINDINGS:

Mean days retained in randomised treatment were-Group 1: 58.9 days; Group 2: 46.6 days; and Group 3: 47.8 days. Differences in retention were not significant using survival analysis. However, nine of the first 60 participants, transferred to the 50 mg dose, and one transferred to a lower dose (chi-square = 0.142; P = 0.018). At follow-up, there was no relationship between abstinence from heroin and naltrexone dose, nor between level of heroin use and dose. There were no differences between groups in craving or depression.

CONCLUSION:

Low doses of naltrexone had no discernible advantage, and participants preferred 50mg per day. Despite preference for blocking doses of naltrexone, outcomes appeared to be independent of naltrexone dose.

• Authors: Felicity Rea, James R Bell, Malcolm R Young, Richard P Mattick
• Journal: Drug and alcohol dependence (Drug Alcohol Depend) Vol. 75 Issue 1 Pg. 79-88 (Jul 15 2004) ISSN: 0376-8716 [Print] Ireland
• PMID: 15225891 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Naltrexone

Topics

• Adolescent
• Adult
• Dose-Response Relationship, Drug
• Female
• Heroin Dependence (drug therapy, psychology)
• Humans
• Male
• Middle Aged
• Naltrexone (administration & dosage)