A Phase 1 interventional study of oxytocin and placebo in Alcoholism and Alcohol Related Disorders, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 21 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-12-04.
Sponsored by Johns Hopkins University · Phase 1, Interventional, and Basic science
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.
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.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 27 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.
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Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
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Exclusion Criteria:
intranasal oxytocin - 40 International Units (IU) dose administered 3 times daily for 1 week
Drug: oxytocin
Intranasal placebo administered 3 times daily for 1 week
Drug: placebo
40 international Units (IU) 3xday delivered as 5 sprays (0.1 mL) per nostril
Also known as: syntocinon
5 sprays (0.1 mL) per nostril 3xday; bottles are identical to those of active drug
Also known as: (Na Cl 0.65%, Phenylcarbinol, Benzalkonium Cl)
Alcohol drinking
Group mean number of Standard Drink Units earned and self-administered in the laboratory session
Time frame: 1 day
alcohol effects
Group mean stimulation and sedation subscale scores on the biphasic alcohol effects scale (BAES), a 14-item scale consisting of adjectives that describe the stimulant- and sedative-like effects of alcohol. The items are presented in alphabetical order, and are rated on an 11-point rating scale from 0=Not at All to 10=Extremely after controlled alcohol administration.
Time frame: 1 day
side effects
side effects reported on the Systematic Assessment for Treatment Emergent Events (SAFTEE)
Time frame: 1 week
Salivary cortisol
Peak and Area under the curve salivary cortisol levels after trier social stress test
Time frame: 1 day
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This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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