MedTrace Logo

Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland

NCT01100853 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-03-06

Study results available
· View outcomes & findings →

Summary

Until positive results were found with oral naltrexone, no medication has been effective against amphetamine dependence. The primary aim of this pilot study is to replicate the findings of the Swedish team that showed oral Naltrexone prevented relapse to amphetamine addiction and to extend their results by randomizing treatment-seeking amphetamine addicted patients to a 6 month course of VIVITROL (naltrexone for extended-release injectable suspension) or VIVITROL placebo. Patients in each group will receive drug counseling. VIVITROL is administered monthly and may be a better test of efficacy than tablets that must be taken daily.

Conditions

  • Amphetamine Dependence

Interventions

DRUG

VIVITROL injection and VIVITROL Placebo Injection , 24 weeks

Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Society of Alcoholism and other Addictions

    collaborator UNKNOWN

  • University of Pennsylvania

    lead OTHER

Principal Investigators

  • Helen Pettinati, Ph.D · University of Pennsylvania

  • George Woody, M.D. · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • Iceland

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01100853 on ClinicalTrials.gov