Status:
COMPLETED
Alcohol and Cigarette Craving During Oxytocin Treatment
Lead Sponsor:
Brown University
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Use Disorder
Smoking
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- understand informed consent and questionnaires written in English at an 8th grade level
- right-handedness
- normal to normal-corrected vision
Exclusion
- positive urine test for pregnancy
- women who are breast-feeding
- body mass index \> 40
- 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
- history of hypersensitivity to oxytocin
- chronic rhinitis or sinusitis
- clinically significant electrolyte abnormalities
- vasoconstricting medications or prostaglandins
- clinically significant medical abnormalities: unstable hypertension, bilirubin \>150% of the upper normal limit (UNL), ALT/AST \>500% the UNL, creatinine clearance ≤60 dl/min)
- significant alcohol withdrawal symptoms, defined as a CIWA-Ar \> 8
- positive urine drug screen at baseline for any excluded substances
- individuals seeking treatment
- meets DSM-5 criteria for a diagnosis of schizophrenia, bipolar disorder, or other psychoses
- claustrophobia
- any contraindications with the MRI machine
Key Trial Info
Start Date :
November 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2024
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04071119
Start Date
November 9 2020
End Date
April 2 2024
Last Update
May 14 2024
Active Locations (1)
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1
Center for Alcohol and Addiction Studies
Providence, Rhode Island, United States, 02912