Alcohol and Cigarette Craving During Oxytocin Treatment (NCT04071119) | Clinical Trial Compass
CompletedPhase 1
Alcohol and Cigarette Craving During Oxytocin Treatment
United States19 participantsStarted 2020-11-09
Plain-language summary
This proposed research seeks to examine the behavioral and neural substrates of intranasal oxytocin compared to placebo on alcohol cue-induced alcohol and cigarette craving smokers with an alcohol use disorder (AUD). Non treatment-seeking smokers with an AUD will be recruited to participate in a between-subjects, placebo-controlled, randomized pilot functional magnetic resonance imaging (fMRI) study. Participants will undergo an fMRI scan in conjunction with an alcohol-olfactory cue-reactivity task. Secondary assessments will include alcohol and cigarette craving, alcohol and cigarette consumption, physiological measures (heart rate and blood pressure) and mood measures.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. male or female
✓. 18 to 55 years of age
✓. meet criteria for Alcohol Use Disorder DSM-5 diagnosis
✓. meet the National Institute on Alcohol Abuse and Alcoholism criteria for heavy-drinking
✓. smoke at least ≥5 cigarettes/day for at least a year, verified with breath carbon monoxide level \> 5 ppm
✓. in good health as confirmed by medical history, physical examination and lab tests
✓. willing to take the medication and adhere to the study procedures
✓. breath alcohol concentration (BrAC) = 0.00 at each visit
✕. current or prior history of any clinically significant disease, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders, positive hepatitis or HIV test that could affect study participation, as determined by the study physician
✕. history of suicide attempts
✕. current diagnosis of substance dependence other than alcohol, nicotine or cannabis as assessed by self-report and urine toxicology screen at baseline
✕. current use of psychoactive medications or any medication that may interact with oxytocin