This is a Phase 2, single-site, randomized, double-blind, placebo-controlled, proof-of-concept (POC) study involving 6 weeks of MAP4343 in conjunction with 6 weeks of manual-guided counseling, with 2 follow-up visits at 1 week and 1 month post-treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Subjects will receive daily oral doses of MAP4343 for 6 weeks in conjunction with 6 weeks of manual-guided counseling
Subjects receive matched placebo for 6 weeks in conjunction with 6 weeks of manual-guided counseling
Subjects receive manually-guided counseling 1 time per week for a 6 week duration
The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
La Jolla, California, United States
Timeline Follow-Back (TLFB) Interview
The Timeline Follow-Back Interview provides quantity and frequency estimates of alcohol consumption for the 90-day period prior to and throughout the study.
Time frame: 90-day period prior to and throughout the study
Visual Analogue Scale of Craving (VAS; adapted from ACQ)
The Visual Analogue Scale of Craving has 4 questions to assess domains of alcohol craving: the intention to drink, loss of control, relief craving, and urge intensity with a 0-20 point visual analogue scale for each item, with 0 indicating no craving and 20 indicating severe craving.
Time frame: At subject's Week 2 human laboratory session
Alcohol Craving Questionnaire-Short Form (ACQ-SF)
The Alcohol Craving Questionnaire-Short Form has 12 questions about alcohol craving which are each scored 1-7, then summed for a weekly score between 7 and 84, with higher scores indicating greater craving.
Time frame: Subjects will followed for up to 10 weeks
Beck Depression Inventory (BDI-II)
The Beck Depression Inventory II consists of 21 questions assessing depression symptoms answered with scores between 0-3, summed for a weekly total score between 0 and 63, higher scores indicate more depression.
Time frame: Subjects will be followed for up to 10 weeks
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index, modified for weekly administration, consists of 9 questions about sleep habits which are answered on a scale of 0-3. Results are sorted into 7 sub scales re-scored 0-3, then sub scales are summed for a weekly total score between 0 and 21, with higher scores indicating greater sleep impairment.
Time frame: Subjects will be followed for up to 10 weeks
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State-Trait Anxiety Inventory (STAI)
The State-Trait Inventory has 20 questions for assessing state anxiety and 20 for trait anxiety answered with scores between 1-4, summed for a weekly total score between 20 and 80, higher scores indicate more anxiety.
Time frame: Subjects will be followed for up to 10 weeks