Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland

This study has been completed.
Sponsor:
Collaborators:
Society of Alcoholism and other Addictions
Information provided by (Responsible Party):
Helen Pettinati, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT01100853
First received: April 7, 2010
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Amphetamine Dependence
Drug: VIVITROL injection and VIVITROL Placebo Injection , 24 weeks
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Number Negative Urines (Proportion Negative Urines) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Number Negative Urines (Proportion Negative Urines) Amphetamine [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amphetamine Craving Scale [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Number of prior admissions due to substance dependence. The term "prior admissions" refers to admissions before enrollment, thus Baseline is the appropriate Time Frame.


Enrollment: 100
Study Start Date: May 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100853

Locations
Iceland
SAA National Center of Addiction Medicine, Vogur Hospital
Storhofoi 45, Reykjavik, Iceland
Sponsors and Collaborators
University of Pennsylvania
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
  More Information

No publications provided

Responsible Party: Helen Pettinati, Principal Investigator, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT01100853     History of Changes
Other Study ID Numbers: 811095, P50DA012756, 2009-013647-10
Study First Received: April 7, 2010
Results First Received: July 9, 2013
Last Updated: November 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
amphetamine dependence
amphetamine injection
VIVITROL/VIVITROL placebo
amphetamine craving

Additional relevant MeSH terms:
Amphetamine-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Amphetamine
Naltrexone
Adrenergic Agents
Adrenergic Uptake Inhibitors
Autonomic Agents
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014