Alcohol and Cigarette Craving During Oxytocin Treatment

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04071119
• Other study ID #: 22301
• Secondary ID: K01AA026874
• Status: Completed
• Phase: Phase 1
• Start date: November 9, 2020
• Est. completion date: April 2, 2024

Study information

• Verified date: May 2024
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 2, 2024
• Est. primary completion date: April 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Smoking

Intervention

Drug:
• Oxytocin nasal spray
Participants administer the oxytocin (40 IU) twice a day for 5 - 7 days
• Placebo
Participants administer the placebo (40 IU) twice a day for 5 - 7 days

Locations

Country	Name	City	State
United States	Center for Alcohol and Addiction Studies	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol craving	average alcohol craving during the cue-reactivity task	1 day
Primary	Cigarette craving	average cigarette craving during the cue-reactivity task	1 day
Primary	Brain activity	BOLD response when comparing alcohol to neutral cues during fMRI	1 day
Secondary	Alcohol and cigarette consumption	alcohol and cigarette consumption assessed by the Timeline Followback	5-7 days