Clinical Trial: Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland

Brief 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.

Detailed Summary:
Sponsor: University of Pennsylvania

Current Primary Outcome:

  • Number Negative Urines (Proportion Negative Urines) [ Time Frame: 24 Weeks ]
  • Number Negative Urines (Proportion Negative Urines) Amphetamine [ Time Frame: 24 weeks ]


Original Primary Outcome: Between group proportions of Amphetamine negative urine tests. [ Time Frame: 24 Weeks ]

Current Secondary Outcome:

  • Amphetamine Craving Scale [ Time Frame: 24 weeks ]
    The Amphetamine Craving Scale is a visual analogue scale, which is scored by indicating the level of craving on a 100 mm line, where 0 is no craving at all and 100 is the highest level of craving experienced. Scores are derived from measuring their placement on the line, yielding scores from 0 to 100.
  • Beck Depression Inventory [ Time Frame: 24 weeks ]
    The Beck Depression Inventory is a self-administered questionnaire that assess the severity of depressive symtpoms. It consists of 21 items about how the subject has been feeling in the last week, and each item has a set of at least four possible answer choices, ranging in intensity, yielding scores from 0-3, with a total possible score of 63. Higher scores indicate more severe depressive symptoms.
  • Risk Assessment Battery [ Time Frame: 24 weeks ]
    The Risk Assessment Battery is a 41 item self-report questionnaire that assess risk behaviors related to HIV infection over the past 6 months. The measure yields a Drug risk score ranging from 0-22 and a Sex risk score ranging from 0-18, with higher scores indicating more risk; these scores are added to yield a Total RAB score ranging from 0-40. This total scores is then divided by 40 to yield a RAB Scale Score from 0-1.
  • Prior Admissions to Vogur Hospital [ Time Frame: Baseline ]
    Number of prior admissions due to substance dependence. The term "prior admissions" refers to admissions before enrollment, thus Baseline is the appropriate Time Frame.


Original Secondary Outcome: Time to relapse: HIV risk behavior; Treatment retention; Amphetamine craving; Use of amphetamine and other drugs; Criminal activity; Depression; Quality of Life [ Time Frame: 24 weeks ]

Information By: University of Pennsylvania

Dates:
Date Received: April 7, 2010
Date Started: May 2010
Date Completion:
Last Updated: November 25, 2013
Last Verified: November 2013