Alcohol and Cigarette Craving During Oxytocin Treatment
NCT ID: NCT04071119
Last Updated: 2024-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
19 participants
INTERVENTIONAL
2020-11-09
2024-04-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Oxytocin nasal spray
Oxytocin nasal spray
Participants administer the oxytocin (40 IU) twice a day for 5 - 7 days
Placebo
Placebo
Participants administer the placebo (40 IU) twice a day for 5 - 7 days
Interventions
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Oxytocin nasal spray
Participants administer the oxytocin (40 IU) twice a day for 5 - 7 days
Placebo
Participants administer the placebo (40 IU) twice a day for 5 - 7 days
Eligibility Criteria
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Inclusion Criteria
2. 18 to 55 years of age
3. meet criteria for Alcohol Use Disorder DSM-5 diagnosis
4. meet the National Institute on Alcohol Abuse and Alcoholism criteria for heavy-drinking
5. smoke at least ≥5 cigarettes/day for at least a year, verified with breath carbon monoxide level \> 5 ppm
6. in good health as confirmed by medical history, physical examination and lab tests
7. willing to take the medication and adhere to the study procedures
8. breath alcohol concentration (BrAC) = 0.00 at each visit
9. understand informed consent and questionnaires written in English at an 8th grade level
10. right-handedness
11. normal to normal-corrected vision
Exclusion Criteria
2. women who are breast-feeding
3. body mass index \> 40
4. 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
5. history of suicide attempts
6. current diagnosis of substance dependence other than alcohol, nicotine or cannabis as assessed by self-report and urine toxicology screen at baseline
7. current use of psychoactive medications or any medication that may interact with oxytocin
8. history of hypersensitivity to oxytocin
9. chronic rhinitis or sinusitis
10. clinically significant electrolyte abnormalities
11. vasoconstricting medications or prostaglandins
12. clinically significant medical abnormalities: unstable hypertension, bilirubin \>150% of the upper normal limit (UNL), ALT/AST \>500% the UNL, creatinine clearance ≤60 dl/min)
13. significant alcohol withdrawal symptoms, defined as a CIWA-Ar \> 8
14. positive urine drug screen at baseline for any excluded substances
15. individuals seeking treatment
16. meets DSM-5 criteria for a diagnosis of schizophrenia, bipolar disorder, or other psychoses
17. claustrophobia
18. any contraindications with the MRI machine
18 Years
55 Years
ALL
No
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Brown University
OTHER
Responsible Party
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Kimberly Goodyear
Assistant Professor
Locations
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Center for Alcohol and Addiction Studies
Providence, Rhode Island, United States
Countries
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Other Identifiers
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22301
Identifier Type: -
Identifier Source: org_study_id
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