Medication Development in Alcoholism: Acamprosate Versus Naltrexone

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara J. Mason, The Scripps Research Institute
ClinicalTrials.gov Identifier:
NCT00656630
First received: April 4, 2008
Last updated: July 19, 2012
Last verified: July 2012
  Purpose

The purpose of this study is to develop and validate a human laboratory model for prediction of medication efficacy in clinical trials for relapse prevention in alcohol dependence. This study involves two laboratory sessions and an fMRI scan.


Condition Intervention Phase
Alcoholism
Drug: Acamprosate
Drug: Naltrexone
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Medication Development in Protracted Abstinence in Alcoholism: Acamprosate Versus Naltrexone

Resource links provided by NLM:


Further study details as provided by The Scripps Research Institute:

Primary Outcome Measures:
  • Urge to Drink [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Affective State [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physiological Reactivity [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Drinking [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Mood [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Sleep [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Craving [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • fMRI Scan [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: December 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Acamprosate
Drug: Acamprosate
Two 333mg capsules, 3 times daily (Total dose, 1998 mg daily), 1 week duration
Active Comparator: 2
Naltrexone
Drug: Naltrexone
50mg capsule, Once daily, 1 week duration
Placebo Comparator: 3 Drug: Placebo
Matched placebo capsule, 1 week duration

Detailed Description:

This is a double-blind, 3-cell, outpatient human laboratory study to determine the degree to which acamprosate and naltrexone will suppress subjective and physiological responsivity to alcohol cues relative to placebo in early abstinence.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females ≥ 18 and ≤ 55 years of age
  • Meets DSM-IV criteria for current alcohol dependence
  • Does not desire treatment
  • Alcohol free, as verified by breath alcohol concentration, with a CIWA ≤ 8, at the time of testing, with no evidence of drinking for at least 3 days but no more than 7 days prior to the cue reactivity session
  • Able to complete and understand questionnaires and study procedures in English
  • Verbal I.Q. estimate ≥ 85
  • Signed informed consent

Exclusion Criteria:

  • Currently meets DSM-IV criteria for dependence on substances other than alcohol or nicotine
  • Significant medical disorders that will increase potential risk or interfere with study participation
  • Sexually active women with childbearing potential who are pregnant, nursing, or refuse to use a reliable method of birth control
  • Meets DSM-IV criteria for a major Axis I disorder, including depression or anxiety disorders
  • Treatment within the month prior to screening with investigational medications or those which may influence drinking outcome, e.g., disulfiram (Antabuse), naltrexone (ReVia), acamprosate (Campral), antidepressants or other psychotropic agents
  • Chronic treatment with any narcotic-containing medications during the previous month or evidence of current opiate use
  • Liver function tests more than three times normal or elevated bilirubin
  • No fixed domicile and/or no availability by telephone or beeper
  • Current involvement in or plans for treatment prior to study completion
  • Patients who have a history of adverse drug reactions to the study drugs or their ingredients
  • Failure to take double-blind medication as prescribed
  • Claustrophobic (MRI is small environment)
  • Non removable metal, e.g., braces (metals are dangerous for MRI)
  • Is in need of or currently taking psychoactive medication (could alter cerebral blood flow characteristics)
  • Inability to understand or comply with the provisions of the protocol or consent form
  • History of neurological disorder, e.g., seizures, meningitis, migraine, HIV, head trauma with loss of consciousness > 2 minutes, or learning disability
  • Left-handed (lateralization interpretations on fMRI are complicated with left-handed subjects
  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: NCT00656630

Locations
United States, California
The Scripps Research Institute
La Jolla, California, United States, 92037
Sponsors and Collaborators
The Scripps Research Institute
Investigators
Principal Investigator: Barbara J Mason, Ph.D. The Scripps Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Barbara J. Mason, PI, The Scripps Research Institute
ClinicalTrials.gov Identifier: NCT00656630     History of Changes
Other Study ID Numbers: AA012602, R01AA012602
Study First Received: April 4, 2008
Last Updated: July 19, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Acamprosate
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Alcohol Deterrents

ClinicalTrials.gov processed this record on October 19, 2014