Laboratory Studies on Oxytocin for Treatment of Alcohol Use Disorder
Condition: Alcoholism; Alcohol Related Disorders
MeSH terms: Alcoholism; Alcohol-Related Disorders
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      This study will lay the necessary groundwork for future comprehensive research to examine the
      utility of the neuropeptide oxytocin (OT) as a potential new medication for the treatment of
      Alcohol use disorder (AUD). OT modulates a number of key systems involved in addiction
      processes, including dopamine (DA) mesolimbic reward circuitry, and
      hypothalamic-pituitary-adrenal (HPA) axis and corticotrophin-releasing factor (CRF) stress
      systems, and has low abuse liability. Our overarching hypothesis is that OT will attenuate
      several measures thought to drive compulsive alcohol drinking and relapse. Specifically,
      investigators will examine whether OT decreases acute stress responses, alleviates alcohol
      withdrawal symptoms, reduces craving and motivation to drink, and decreases alcohol
      self-administration. Since interactions with alcohol are an important focus of our study,
      investigators will enroll non-treatment seeking heavy drinkers with AUD in a double blind,
      placebo controlled inpatient protocol. Subjects will be randomized to receive intranasal OT
      (40 IU/dose) or placebo 3 times daily. Participants will complete alcohol detoxification;
      investigators will measure alcohol withdrawal symptoms, craving, and 24-hr urinary free CORT.
      Participants will then complete 3 laboratory procedures in fixed order. The Trier Social
      Stress Test (TSST) which includes public speaking and performance of mental arithmetic will
      be used to examine subjective and physiological stress responses. An alcohol motivated
      responding (AMR) procedure will be used to examine subjects' responding to earn either drinks
      or money. A cumulative alcohol-dosing (CAD) procedure will be used to examine physiological
      and subjective responses across several blood alcohol levels. cortisol (CORT) levels will
      also be assessed. This study will provide new information on OT efficacy across a range of
      different measures predictive of alcohol use and misuse, and, if OT shows efficacy, help
      clarify the mechanism of OT action.
    

Intervention name(s): oxytocin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40 international Units (IU) 3xday delivered as 5 sprays (0.1 mL) per nostril; 5 sprays (0.1 mL) per nostril 3xday; bottles are identical to those of active drug
Other intervention name(s): syntocinon; (Na Cl 0.65%, Phenylcarbinol, Benzalkonium Cl)
Intervention MeSH terms: Benzalkonium Compounds; Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Oxytocin vs. placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Alcohol Withdrawal Delirium