Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland

Phase 3

Completed

• Conditions: Amphetamine Dependence
• Interventions: Drug: VIVITROL injection and VIVITROL Placebo Injection , 24 weeks

• Registration Number: NCT01100853
• Lead Sponsor: University of Pennsylvania

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 Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-04-07
• Study First Submitted QC: 2010-04-07
• Study First Posted: 2010-04-09
• Study Start: 2010-05
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Results First Submitted: 2013-07-09
• Results First Submitted QC: 2013-11-25
• Results First Posted: 2014-01-13
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-02
• Last Update Posted: 2018-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Age 18 or above;
2. Diagnosis of amphetamine dependence as defined by DSM-IV-TR with 10 or more days of amphetamine use in the past month, and patient and clinician identify amphetamine dependence as the main problem;
3. Abstinent from substances (alcohol, amphetamines, cannabinoid, cocaine, hallucinogens, opioids, benzodiazepines [unless used to treat alcohol withdrawal] for at least 7 days prior to receiving study drug or placebo;
4. Provision of telephone numbers/contacts of three or more people that are likely to know where can be located if unable to be contacted directly;
5. Successfully complete 7-10 day assessment and study baseline measures at Vogur

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Exclusion Criteria

1. Any liver test >5 times the top limit of normal; Physiologically dependent on opioids or other substances (nicotine excepted) at time of admission to Vogur;
2. Suspected or known concomitant use of opioid analgesics, positive opioid urine drug test or positive naloxone challenge:
3. Schizophrenia, Bipolar I or other non-substance related psychotic disorder; Severely depressed, suicidal or homicidal: Dementia: Inability to understand the informed consent;
4. Planning to move from the Reykjavík area or enter jail within the next 12 months;
5. Likely to receive opioid analgesics in next 6 months associated with possible or scheduled surgery or procedure;
6. Known hypersensitivity to naltrexone, polyactide-co-glycolide (PLG); carboxymethylcellulose, or any other component of the diluent;
7. Female subjects who are pregnant or lactating, or of child bearing potential who are not using acceptable methods of birth control;
8. A body habitus that precludes use of the customized needle for intramuscular injection, based on clinical judgment;
9. Use of an investigational agent in the past 30 days

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extended release VIVITROL injection 380 mg, 24 weeks	VIVITROL injection and VIVITROL Placebo Injection , 24 weeks	Efficacy of 24 week course of Extended Release VIVITROL 380 mg with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
VIVITROL placebo injection, 24 weeks	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)

Primary Outcome Measures

Name	Time	Method
Number Negative Urines (Proportion Negative Urines)	24 Weeks
Number Negative Urines (Proportion Negative Urines) Amphetamine	24 weeks

Secondary Outcome Measures

Name	Time	Method
Amphetamine Craving Scale	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	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	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	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.

Trial Locations

Locations (1)

SAA National Center of Addiction Medicine, Vogur Hospital; 🇮🇸 Storhofda 45, Reykjavík, Iceland