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OpenTrials
Completed

NCT Number: NCT04071119

Alcohol and Cigarette Craving 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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Center for Alcohol and Addiction Studies

Providence, Rhode Island, 02912, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxytocin nasal spray

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Alcohol craving

    Time frame: 1 day

    average alcohol craving during the cue-reactivity task

  2. Cigarette craving

    Time frame: 1 day

    average cigarette craving during the cue-reactivity task

  3. Brain activity

    Time frame: 1 day

    BOLD response when comparing alcohol to neutral cues during fMRI

Secondary outcomes

  1. Alcohol and cigarette consumption

    Time frame: 5-7 days

    alcohol and cigarette consumption assessed by the Timeline Followback

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 28, 2019
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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