Medication Development in Alcoholism: Acamprosate Versus Naltrexone
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|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|
|Actual Primary Completion Date :||January 2010|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|