Laboratory Studies on Oxytocin for Treatment of Alcohol Use Disorder
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - 50 |
| Updated: | 12/6/2017 |
| Start Date: | March 2015 |
| End Date: | June 15, 2017 |
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.
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.
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.
Inclusion Criteria:
- Healthy 21-50 years old male and female subjects
- Must meet Diagnostic and Statistical Manual (DSM) -V criteria for AUD and not be
seeking treatment
- Actively drinking
- Positive blood phosphatidylethanol (PEth) blood test
Exclusion Criteria:
- Current DSM-V major current mood or anxiety disorder or drug use disorder (excluding
alcohol and nicotine use disorders, and moderate-severe cannabis use disorder); in or
in need of treatment
- Drug use in last 30 days and/or positive urine toxicology screens (excluding
marijuana)
- History of seizure disorder or closed head trauma
- History of withdrawal-related seizures or serious alcohol withdrawal symptoms
- HIV positive
- Neuroendocrine disorder
- Any serious medical condition that would place subject at risk or interfere with study
participation
- Liver function tests more than 3 times normal at screening
- Prescription medications in last 3 months that could affect central nervous system or
HPA axis function
- Women who are pregnant, nursing or planning pregnancy cannot participate
We found this trial at
1
site
3400 N Charles St
Baltimore, Maryland 21205
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Elise M. Weerts, PhD
Phone: 410-955-9524
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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