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Medication Development in Alcoholism: Acamprosate Versus Naltrexone

Primary Purpose

Alcoholism

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Acamprosate
Naltrexone
Placebo
Sponsored by
The Scripps Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alcoholism

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Scripps Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

Arm Description

Acamprosate

Naltrexone

Outcomes

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
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
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
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
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
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.

Full Information

First Posted
April 4, 2008
Last Updated
February 8, 2017
Sponsor
The Scripps Research Institute
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00656630
Brief Title
Medication Development in Alcoholism: Acamprosate Versus Naltrexone
Official Title
Medication Development in Protracted Abstinence in Alcoholism: Acamprosate Versus Naltrexone
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Scripps Research Institute
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Acamprosate
Arm Title
2
Arm Type
Active Comparator
Arm Description
Naltrexone
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Acamprosate
Other Intervention Name(s)
Campral
Intervention Description
Two 333mg capsules, 3 times daily (Total dose, 1998 mg daily), 1 week duration
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Other Intervention Name(s)
ReVia
Intervention Description
50mg capsule, Once daily, 1 week duration
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
Matched placebo capsule, 1 week duration
Primary Outcome Measure Information:
Title
Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Acamprosate or Naltrexone or Placebo During the Double-Blind Period
Description
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.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Change From Baseline in Standard Drinks Per Week at 1 Week
Description
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.
Time Frame
1 week
Title
Change From Baseline in Mood on the Beck Depression Inventory (BDI-II) at Week 1
Description
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.
Time Frame
1 week
Title
Change From Baseline in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) Total Score at Week 1
Description
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.
Time Frame
1 week
Title
Change From Screening in Craving on the Alcohol Craving Questionnaire-Short Form (ACQ-SF) Total Score at Week 1
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara J Mason, Ph.D.
Organizational Affiliation
The Scripps Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Scripps Research Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.pearsoncenter.org
Description
Related Info

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Medication Development in Alcoholism: Acamprosate Versus Naltrexone

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