Alcohol and Cigarette Craving During Oxytocin Treatment

Sponsor

Brown University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04071119

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)

Enrollment

Location

Arms

45.7

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use Disorder Smoking	Drug: Oxytocin nasal spray Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

55 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

The Neural Mechanisms Associated With Alcohol and Cigarette Craving in Alcohol Use Disorder Smokers During Oxytocin Treatment

Actual Study Start Date :

Nov 9, 2020

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Oxytocin nasal spray	Drug: Oxytocin nasal spray Participants administer the oxytocin (40 IU) twice a day for 5 - 7 days
Placebo Comparator: Placebo	Drug: Placebo Participants administer the placebo (40 IU) twice a day for 5 - 7 days

Arm

Intervention/Treatment

Active Comparator: Oxytocin nasal spray

Drug: Oxytocin nasal spray

Participants administer the oxytocin (40 IU) twice a day for 5 - 7 days

Placebo Comparator: Placebo

Drug: Placebo

Participants administer the placebo (40 IU) twice a day for 5 - 7 days

Outcome Measures

Primary Outcome Measures

Alcohol craving [1 day]
average alcohol craving during the cue-reactivity task
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

Secondary Outcome Measures

Alcohol and cigarette consumption [5-7 days]
alcohol and cigarette consumption assessed by the Timeline Followback

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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