Clinical trial NCT04071119: Alcohol and Cigarette Craving During Oxytocin Treatment
Official title: The Neural Mechanisms Associated With Alcohol and Cigarette Craving in Alcohol Use Disorder Smokers During Oxytocin Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alcohol Use Disorder
Smoking
Keywords: oxytocin
craving
alcohol use disorder
smoking
cigarettes
drinking
functional magnetic resonance imaging
cue-reactivity
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-08-28
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Alcohol craving
timeFrame: 1 day
measure: Cigarette craving
timeFrame: 1 day
measure: Brain activity
timeFrame: 1 day
Secondary outcomes:
measure: Alcohol and cigarette consumption
timeFrame: 5-7 days
Other outcomes:
Locations:
city: Providence
country: United States
facility: Center for Alcohol and Addiction Studies
state: Rhode Island
Study officials:
References: