Alcohol Use Disorder, Smoking
Conditions
Keywords
oxytocin, craving, alcohol use disorder, smoking, cigarettes, drinking, functional magnetic resonance imaging, cue-reactivity
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 disorder (AUD). Non treatment-seeking smokers with an AUD will be recruited to participate in a between-subjects, placebo-controlled, randomized pilot functional magnetic resonance imaging (fMRI) study. Participants will undergo an fMRI scan in conjunction with an alcohol-olfactory cue-reactivity task. Secondary assessments will include alcohol and cigarette craving, alcohol and cigarette consumption, physiological measures (heart rate and blood pressure) and mood measures.
Interventions
DRUGOxytocin nasal spray
Participants administer the oxytocin (40 IU) twice a day for 5 - 7 days
DRUGPlacebo
Participants administer the placebo (40 IU) twice a day for 5 - 7 days
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. male or female 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
1. positive urine test for pregnancy 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cigarette craving | 1 day | average cigarette craving during the cue-reactivity task |
| Brain activity | 1 day | BOLD response when comparing alcohol to neutral cues during fMRI |
| Alcohol craving | 1 day | average alcohol craving during the cue-reactivity task |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol and cigarette consumption | 5-7 days | alcohol and cigarette consumption assessed by the Timeline Followback |
Countries
United States
Outcome results
None listed