Naltrexone for Individuals of East Asian Descent
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02026011|
Recruitment Status : Completed
First Posted : January 1, 2014
Results First Posted : July 17, 2019
Last Update Posted : July 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Use Disorder||Drug: Naltrexone Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||87 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Optimizing Naltrexone for Individuals of East Asian Descent|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
Naltrexone 50 mg/day
Naltrexone is an opioid receptor antagonist with highest affinity for mu opioid receptors
Placebo Comparator: Sugar pill
Sugar pill, matched to the active study medication in capsule size and color
Other Name: Sugar pill
- Subjective Response - Craving for Alcohol [ Time Frame: The AUQ was administered across a period of approximately 1.5 hours. ]Alcohol Urge Questionnaire (AUQ) is used to assess subjective experiences of craving for alcohol. It consists of 8 items, each rated on a 7-point Likert scale (1 = strongly disagree, 7 = strongly agree). A summary score is used at each assessment time point. The AUQ was administered at baseline and three levels of breath alcohol concentration: 0.02 g/dl. 0.04, g/dl, and 0.06 g/dl.
- Subjective Response - Stimulation [ Time Frame: The BAES Stimulant Subscale was administered at baseline and three levels of breath alcohol concentration: 0.2 g/dl. 0.04, g/dl, and 0.06 g/dl taking place within approximately 1.5 hours ]The Biphasic Alcohol Effects Scale (BAES) Stimulant Subscale consists of 14 items designed to capture the stimulant effects of alcohol, rated on an 11-point scale (0 = not at all. 10 = extremely). Total score for the stimulant subscale ranges from 0-70.
- Subjective Response - Sedation [ Time Frame: The BAES Sedation Subscale was administered at baseline and three levels of breath alcohol concentration: 0.2 g/dl. 0.04, g/dl, and 0.06 g/dl taking place within approximately 1.5 hours ]The Biphasic Alcohol Effects Scale (BAES) Sedation Subscale consists of 14 items designed to capture the sedating effects of alcohol, rated on an 11-point scale (0 = not at all. 10 = extremely). Total score for the sedation subscale ranges from 0-70.
- Neural Response to Alcohol Cues [ Time Frame: During the alcohol cue exposure fMRI paradigm which is expected to last 45 minutes ]Alcohol taste cues task for functional magnetic resonance imaging (fMRI). Region of Interest (ROI) were atomically defined using the Harvard-Oxford atlas in standard Montreal Neurological Institute (MNI) space, which were transformed into individual participants' native space using Functional Magnetic Resonance Imaging of the Brain Software Library (FSL). Contrast estimates are for Alc > Water cue, and are arbitrary units.
- Alcohol Self-administration - Number of Drinks [ Time Frame: Alcohol self-administration period was 1 hour long ]Total number of drinks consumed during the alcohol self-administration task
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): NCT02026011
|United States, California|
|UCLA Addictions Laboratory|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Lara Ray, PhD||University of California, Los Angeles|