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Medication Development in Alcoholism: Acamprosate Versus Naltrexone

This study has been completed.
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Barbara J. Mason, The Scripps Research Institute
ClinicalTrials.gov Identifier:
NCT00656630
First received: April 4, 2008
Last updated: February 8, 2017
Last verified: February 2017
  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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Other
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:
  • Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Acamprosate or Naltrexone or Placebo During the Double-Blind Period [ Time Frame: 1 week ]
    The four Visual Analog Scale questions assess domains of alcohol craving: the intention to drink, loss of control, relief craving, and urge intensity. The scale ranges from 0-20 where a zero indicates no craving and 20 indicates severe craving; thus, a higher score indicates a worse outcome. Total is a summation of the four subscales (i.e. Strength, Intent, Impulse, Relief) and ranges in value from 0-80 with higher scores indicative of a worse outcome.


Secondary Outcome Measures:
  • Change From Baseline in Standard Drinks Per Week at 1 Week [ Time Frame: 1 week ]
    Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 1 - Baseline). More negative values indicate less use of alcohol.

  • Change From Baseline in Mood on the Beck Depression Inventory (BDI-II) at Week 1 [ Time Frame: 1 week ]
    The BDI-II is a self-rating of severity of depressive symptoms. BDI-II Total scores range from 0-63; a lower score indicates less severe depressive systems and thus is a better outcome. Change = (Week 1 score - Baseline score). The Total score is a sum of the 21 items on the BDI-II instrument, with each item rated from 0-3.

  • Change From Baseline in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) Total Score at Week 1 [ Time Frame: 1 week ]
    The PSQI is an instrument to assess subjective sleep quality and disturbance. The Total score ranges from 0 to 21 where a lower score is better sleep quality. Change = (Week 1 score - Baseline score). Seven subscales (range 0-3) are summed to compute the Total score.

  • Change From Screening in Craving on the Alcohol Craving Questionnaire-Short Form (ACQ-SF) Total Score at Week 1 [ Time Frame: 2 weeks ]
    The ACQ-SF is an assessment of current drinking urges, difficulty resisting urge and anticipation of positive outcome or relief from negative state by drinking. The Total score ranges from 0 to 7 where a lower score is a better outcome. Change = (Week 1 score - Screening score). The scale is comprised of twelve items (range 0-7) that are averaged to compute the Total score.


Enrollment: 68
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
Other Name: Campral
Active Comparator: 2
Naltrexone
Drug: Naltrexone
50mg capsule, Once daily, 1 week duration
Other Name: ReVia
Placebo Comparator: 3 Drug: Placebo
Matched placebo capsule, 1 week duration
Other Name: Sugar pill

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   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females ≥ 18 and ≤ 55 years of age
  • Meets Diagnostic and Statistical Manual-Fourth Edition (DSM-IV) criteria for current alcohol dependence
  • Does not desire treatment
  • Alcohol free, as verified by breath alcohol concentration, with a Clinical Institute Withdrawal Assessment (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
  • Inability to understand or comply with the provisions of the protocol or consent form
  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
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Barbara J Mason, Ph.D. The Scripps Research Institute
  More Information

Additional Information:
Responsible Party: Barbara J. Mason, PI, The Scripps Research Institute
ClinicalTrials.gov Identifier: NCT00656630     History of Changes
Other Study ID Numbers: AA012602
R01AA012602 ( US NIH Grant/Contract Award Number )
Study First Received: April 4, 2008
Results First Received: December 14, 2016
Last Updated: February 8, 2017

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

ClinicalTrials.gov processed this record on April 28, 2017