This study will evaluate the safety and exploratory efficacy of AFA-281 in patients with Alcohol use disorder on cravings, subjective response to alcohol, pain thresholds, anxiety, depression, and sleep.
Age between 21 and 65
Must voluntarily sign and date each informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures.
Meet current (i.e., past 12 months) DSM-5 diagnostic criteria for moderate or severe AUD
Report drinking at least 28 drinks per week if male, 21 drinks per week if female, in the 28 days prior to consent.
Current treatment for alcohol use or a history of treatment in the 30 days before enrollment or treatment seeking
Current (last 12 months) DSM-5 diagnosis of dependence on any psychoactive substances other than nicotine
Current DSM-5 diagnosis of substance use disorder for any substance other than alcohol and nicotine
Lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder
Parallel
AFA-281
DrugAFA-281
Cue-induced alcohol craving
Questionnaire measures the level of alcohol craving
Stress-induced alcohol craving
Alcohol urge questionnaire after stressful stimuli
Subjective response to alcohol
Biphasic alcohol effects scale and profile of negative mood states
Pain assessments
Latency to first feel pain and pain intensity scoring using the McGill Pain Questionnaire
Daily diary report
Examination of clinically relevant phenotypes by daily diary reports of alcohol use, alcohol craving, anxiety, depression, subjective pain and sleep
This trial is not recruiting at the moment. You can still explore other options:
