Alcohol and Cigarette Craving During Oxytocin Treatment

Study Overview
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Brief Summary
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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.

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

Conditions
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Alcohol Use Disorder, Smoking

Intervention / Treatment
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* Drug: Oxytocin nasal spray
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxytocin, craving, alcohol use disorder, smoking, cigarettes, drinking, functional magnetic resonance imaging, cue-reactivity