Alcohol and Cigarette Craving During Oxytocin Treatment

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Alcohol Use Disorder
• Intervention / Treatment: Drug: Oxytocin nasal spray; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Kimberly Goodyear, Ph.D.; Phone Number: 401-863-6626; Email: kimberly_goodyear@brown.edu

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Center for Alcohol and Addiction Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol craving	average alcohol craving during the cue-reactivity task	1 day
Cigarette craving	average cigarette craving during the cue-reactivity task	1 day
Brain activity	BOLD response when comparing alcohol to neutral cues during fMRI	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol and cigarette consumption	alcohol and cigarette consumption assessed by the Timeline Followback	5-7 days

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2020
• Primary Completion (Actual): February 24, 2023
• Study Completion (Actual): February 24, 2023

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: craving; functional magnetic resonance imaging; oxytocin; smoking; drinking; cigarettes; alcohol use disorder; cue-reactivity
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: 22301; K01AA026874 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No