Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland

NCT ID: NCT01100853

Last Updated: 2018-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2013-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

VIVITROL injection and VIVITROL Placebo Injection , 24 weeks

Intervention Type: DRUG

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

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)

Group Type: PLACEBO_COMPARATOR

VIVITROL injection and VIVITROL Placebo Injection , 24 weeks

Intervention Type: DRUG

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

Interventions

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)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Society of Alcoholism and other Addictions

UNKNOWN

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helen Pettinati, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

George Woody, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

SAA National Center of Addiction Medicine, Vogur Hospital

Storhofda 45, Reykjavík, Iceland

Countries

Iceland

Other Identifiers

P50DA012756

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2009-013647-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

811095

Identifier Type: -

Identifier Source: org_study_id