drugset / Trial / NCT02407340

Laboratory Studies on Oxytocin for Treatment of Alcohol Use Disorder

NCT02407340

Phase 1 Completed 27 enrolled Johns Hopkins University
RandomizedParallel-groupQuadruple-blindBasic science

Summary

This study will examine the utility of the neuropeptide oxytocin (OT) as a potential new medication for the treatment of Alcohol use disorder (AUD). Non-treatment seeking men and women with AUD will be enrolled in a double blind placebo controlled phase I clinical trial. Participants will complete an 7-day inpatient protocol. During the first 3 days of the inpatient protocol, participants will complete alcohol abstinence in which withdrawal symptoms are measured,and urine will be collected to determine withdrawal symptom severity and urine levels of the stress hormone cortisol. Participants will then complete 3 laboratory procedures which measure 1) stress response, 2) motivation to drink alcohol and 3) subjective and physiological effects of alcohol. Finally, because participants are individuals with AUD, investigators will administer a brief intervention to address their risky alcohol drinking and problems before discharge.

Timeline

Start
2015-03
Primary completion
2017-06-15
Completion
2017-06-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Oxytocin Peptide 40 iu Intranasal

Indications