Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland

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.

Study Overview

• Status: Completed
• Conditions: Amphetamine Dependence
• Intervention / Treatment: Drug: VIVITROL injection and VIVITROL Placebo Injection , 24 weeks

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iceland
  • Reykjavík
    • Storhofda 45, Reykjavík, Iceland, 112
      • SAA National Center of Addiction Medicine, Vogur Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Extended release VIVITROL injection 380 mg, 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)	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)
Placebo Comparator: 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)	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number Negative Urines (Proportion Negative Urines)	24 Weeks
Number Negative Urines (Proportion Negative Urines) Amphetamine	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amphetamine Craving Scale	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.	24 weeks
Beck Depression Inventory	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.	24 weeks
Risk Assessment Battery	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.	24 weeks
Prior Admissions to Vogur Hospital	Number of prior admissions due to substance dependence. The term "prior admissions" refers to admissions before enrollment, thus Baseline is the appropriate Time Frame.	Baseline

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute on Drug Abuse (NIDA); Society of Alcoholism and other Addictions
• Investigators: Principal Investigator: Helen Pettinati, Ph.D, University of Pennsylvania; Principal Investigator: George Woody, M.D., University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: April 7, 2010
• First Submitted That Met QC Criteria: April 7, 2010
• First Posted (Estimate): April 9, 2010

Study Record Updates

• Last Update Posted (Actual): March 6, 2018
• Last Update Submitted That Met QC Criteria: March 2, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: amphetamine dependence; amphetamine injection; VIVITROL/VIVITROL placebo; amphetamine craving
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Amphetamine-Related Disorders; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Alcohol Deterrents; Naltrexone
• Other Study ID Numbers: 811095; P50DA012756 (U.S. NIH Grant/Contract); 2009-013647-10 (EudraCT Number)