Alcohol and Cigarette Craving During Oxytocin Treatment
Primary Purpose
Alcohol Use Disorder, Smoking
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oxytocin nasal spray
Placebo
Sponsored by
About this trial
This is an interventional other trial for Alcohol Use Disorder focused on measuring oxytocin, craving, alcohol use disorder, smoking, cigarettes, drinking, functional magnetic resonance imaging, cue-reactivity
Eligibility Criteria
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
Sites / Locations
- Center for Alcohol and Addiction StudiesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Oxytocin nasal spray
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Alcohol craving
average alcohol craving during the cue-reactivity task
Cigarette craving
average cigarette craving during the cue-reactivity task
Brain activity
BOLD response when comparing alcohol to neutral cues during fMRI
Secondary Outcome Measures
Alcohol and cigarette consumption
alcohol and cigarette consumption assessed by the Timeline Followback
Full Information
NCT ID
NCT04071119
First Posted
August 23, 2019
Last Updated
February 28, 2022
Sponsor
Brown University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT04071119
Brief Title
Alcohol and Cigarette Craving During Oxytocin Treatment
Official Title
The Neural Mechanisms Associated With Alcohol and Cigarette Craving in Alcohol Use Disorder Smokers During Oxytocin Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2020 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Smoking
Keywords
oxytocin, craving, alcohol use disorder, smoking, cigarettes, drinking, functional magnetic resonance imaging, cue-reactivity
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oxytocin nasal spray
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Oxytocin nasal spray
Intervention Description
Participants administer the oxytocin (40 IU) twice a day for 5 - 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants administer the placebo (40 IU) twice a day for 5 - 7 days
Primary Outcome Measure Information:
Title
Alcohol craving
Description
average alcohol craving during the cue-reactivity task
Time Frame
1 day
Title
Cigarette craving
Description
average cigarette craving during the cue-reactivity task
Time Frame
1 day
Title
Brain activity
Description
BOLD response when comparing alcohol to neutral cues during fMRI
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Alcohol and cigarette consumption
Description
alcohol and cigarette consumption assessed by the Timeline Followback
Time Frame
5-7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kimberly Goodyear, Ph.D.
Phone
401-863-6626
Email
kimberly_goodyear@brown.edu
Facility Information:
Facility Name
Center for Alcohol and Addiction Studies
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Goodyear, Ph.D.
First Name & Middle Initial & Last Name & Degree
Robert M Swift, M.D., Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
No
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Alcohol and Cigarette Craving During Oxytocin Treatment
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