Alcohol and Cigarette Craving During Oxytocin Treatment

NCT04071119 | Completed Phase 1 FDA Drug

• 2 other identifiers: 22301K01AA026874
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder; Smoking

Keywords

oxytocin; craving; alcohol use disorder; smoking; cigarettes; drinking; functional magnetic resonance imaging; cue-reactivity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Alcohol and cigarette consumption

  5-7 days

Study Arms (2)

Oxytocin nasal spray

ACTIVE COMPARATOR

Drug: Oxytocin nasal spray

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Oxytocin nasal spray DRUG

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

Oxytocin nasal spray

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• male or female
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brown University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Center for Alcohol and Addiction Studies

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Alcoholism; Smoking

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: November 9, 2020
• Primary Completion: April 2, 2024
• Study Completion: April 2, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)