Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland

NCT01100853 | Completed Phase 3 Results

• 3 other identifiers: 811095P50DA0127562009-013647-10
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Amphetamine Dependence

Keywords

amphetamine dependence; amphetamine injection; VIVITROL/VIVITROL placebo; amphetamine craving

Outcome Measures

Primary Outcomes (2)

• Number Negative Urines (Proportion Negative Urines)

  24 Weeks

• Number Negative Urines (Proportion Negative Urines) Amphetamine

  24 weeks

Secondary Outcomes (4)

• Amphetamine Craving Scale

  24 weeks

• Beck Depression Inventory

  24 weeks

• Risk Assessment Battery

  24 weeks

• Prior Admissions to Vogur Hospital

  Baseline

Study Arms (2)

Extended release VIVITROL injection 380 mg, 24 weeks

ACTIVE COMPARATOR

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

VIVITROL placebo injection, 24 weeks

PLACEBO COMPARATOR

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

Interventions

VIVITROL injection and VIVITROL Placebo Injection , 24 weeks DRUG

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

Extended release VIVITROL injection 380 mg, 24 weeks; VIVITROL placebo injection, 24 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or above;
• 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;
• 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;
• 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;
• Successfully complete 7-10 day assessment and study baseline measures at Vogur

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Society of Alcoholism and other Addictions: collaborator

Study Sites (1)

SAA National Center of Addiction Medicine, Vogur Hospital

Storhofda 45, Reykjavík, 112, Iceland

Location

MeSH Terms

Conditions

Amphetamine-Related Disorders

Interventions

vivitrol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Helen Pettinati
• Organization: University of Pennsylvania

helenp@mail.med.upenn.edu

215-222-3200

Study Officials

• Helen Pettinati, Ph.D

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• George Woody, M.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2010
• First Posted: April 9, 2010
• Study Start: May 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: March 6, 2018
• Results First Posted: January 13, 2014

Record last verified: 2018-03

Locations

IC (1)