Medication Development in Alcoholism: Acamprosate Versus Naltrexone
|ClinicalTrials.gov Identifier: NCT00656630|
Recruitment Status : Completed
First Posted : April 11, 2008
Results First Posted : March 29, 2017
Last Update Posted : March 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Alcoholism||Drug: Acamprosate Drug: Naltrexone Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Medication Development in Protracted Abstinence in Alcoholism: Acamprosate Versus Naltrexone|
|Study Start Date :||December 2007|
|Primary Completion Date :||January 2010|
|Study Completion Date :||January 2010|
Active Comparator: 1
Two 333mg capsules, 3 times daily (Total dose, 1998 mg daily), 1 week duration
Other Name: Campral
Active Comparator: 2
50mg capsule, Once daily, 1 week duration
Other Name: ReVia
|Placebo Comparator: 3||
Matched placebo capsule, 1 week duration
Other Name: Sugar pill
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656630
|United States, California|
|The Scripps Research Institute|
|La Jolla, California, United States, 92037|
|Principal Investigator:||Barbara J Mason, Ph.D.||The Scripps Research Institute|