Back to resultsOxytocin on Approach Bias and Craving
Primary Purpose
Alcohol Use Disorder
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorder
Eligibility Criteria
Inclusion Criteria:
- Healthy volunteers who are 21-40 years of age
- If female, 10 or more alcoholic drinks must be consumed weekly.
- If male, 14 or more alcoholic drinks must be consumed weekly.
- Meets DSM-V criteria for Alcohol Use Disorder (AUD).
- Score 8 or greater on the Alcohol Use Disorders Identification Test (AUDIT)
- If female, must be non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device [IUD], hormonal birth control, or barrier method).
- Native English speaker
- Right handed
- High school graduate or equivalent.
- Able and willing to provide an informed consent.
- Able to understand and follow the instructions of the investigator
Exclusion Criteria:
- Positive urine drug screen (except marijuana).
- Using cocaine, stimulants (other than nicotine and caffeine), amphetamines, hallucinogens, ecstasy, opiates, sedatives, pain pills, sleeping pills, or other psychoactive drugs within 2 weeks of the start of the study (except marijuana).
- Marijuana use more than 3 times/week.
- Current enrollment in an alcohol, or other drug treatment program or current legal problems relating to alcohol, or other drug use.
- Currently trying to quit alcohol use.
- History of major alcohol related complications within the preceding 2 years (liver failure/cirrhosis, pancreatitis, esophageal varices, etc.).
- Has a history of atrophic rhinitis, recurrent nose bleeds, cranial surgical procedures, hypophysectomy, chronic congestion, or sinus problems.
- Has a history of cardiac arrhythmia.
- Clinically significant medical or psychiatric illness requiring treatment as determined by screening blood tests, medical history, and/or physical exam performed or reviewed by the study physician.
- Severely low blood (< 90/50) pressure or uncontrolled high blood pressure (>160/100).
- SGPT/ALT or SGOT/AST values greater than 2x upper limit of normal.
- BAC level > 0.00% at the beginning of screening visit (within margin of error of detection).
- Has a neurological dysfunction or psychiatric disorder (confirm with study physician).
- Has a history of brain trauma (confirm with study physician).
- Has an allergy or intolerance to oxytocin.
- Has received an investigational drug within 30 days of Screening Visit.
- Has any MRI scanning contraindications.
- Has a history of claustrophobia.
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Oxytocin First
Placebo First
Arm Description
Subjects will receive oxytocin prior to their first scanning session, and placebo prior to their second scanning session.
Subjects will receive placebo prior to their first scanning session, and oxytocin prior to their second scanning session.
Outcomes
Primary Outcome Measures
Alcohol cue craving score
Subjects will be asked to perform a standardized alcohol cue exposure paradigm and be asked to rate their subjective craving following alcohol cue presentation using a standard visual analog scale. Craving scores (ranging from 1-10 on VAS) will be compared across both the active study drug and placebo.
Image approach task
Subjects will be asked to perform an image approach task where subjects are presented with a series of images and asked to pull or push a joystick following each presentation. Response direction and speed are recorded and compared across both the active study drug and placebo.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03865615
Brief Title
Oxytocin on Approach Bias and Craving
Official Title
The Effects of Intranasal Oxytocin on Approach Bias and Craving in Moderate to Heavy Alcohol Drinkers
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Withdrawn
Why Stopped
COVID made study visits impossible during the funding period.
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
April 20, 2024 (Anticipated)
Study Completion Date
April 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jennifer Mitchell
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 will be a laboratory-based investigation of the behavioral and neural effects of intranasal oxytocin on craving for alcohol and approach bias in moderate to heavy alcohol using subjects. This study uses a within-subject, randomized, placebo-controlled, counterbalanced, crossover design to compare the effects oxytocin and placebo. In this way, all subjects will be scanned twice; once following oxytocin administration and once following placebo administration, and will complete a series of behavioral tasks (both in and out of the scanner) at both visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Within-subject, randomized, placebo-controlled, counterbalanced, crossover design.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxytocin First
Arm Type
Experimental
Arm Description
Subjects will receive oxytocin prior to their first scanning session, and placebo prior to their second scanning session.
Arm Title
Placebo First
Arm Type
Experimental
Arm Description
Subjects will receive placebo prior to their first scanning session, and oxytocin prior to their second scanning session.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Syntocinon
Intervention Description
intranasal oxytocin 40IU/mL
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Alcohol cue craving score
Description
Subjects will be asked to perform a standardized alcohol cue exposure paradigm and be asked to rate their subjective craving following alcohol cue presentation using a standard visual analog scale. Craving scores (ranging from 1-10 on VAS) will be compared across both the active study drug and placebo.
Time Frame
~ 90 minutes post study drug administration
Title
Image approach task
Description
Subjects will be asked to perform an image approach task where subjects are presented with a series of images and asked to pull or push a joystick following each presentation. Response direction and speed are recorded and compared across both the active study drug and placebo.
Time Frame
~ 90 minutes post study drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers who are 21-40 years of age
If female, 10 or more alcoholic drinks must be consumed weekly.
If male, 14 or more alcoholic drinks must be consumed weekly.
Meets DSM-V criteria for Alcohol Use Disorder (AUD).
Score 8 or greater on the Alcohol Use Disorders Identification Test (AUDIT)
If female, must be non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device [IUD], hormonal birth control, or barrier method).
Native English speaker
Right handed
High school graduate or equivalent.
Able and willing to provide an informed consent.
Able to understand and follow the instructions of the investigator
Exclusion Criteria:
Positive urine drug screen (except marijuana).
Using cocaine, stimulants (other than nicotine and caffeine), amphetamines, hallucinogens, ecstasy, opiates, sedatives, pain pills, sleeping pills, or other psychoactive drugs within 2 weeks of the start of the study (except marijuana).
Marijuana use more than 3 times/week.
Current enrollment in an alcohol, or other drug treatment program or current legal problems relating to alcohol, or other drug use.
Currently trying to quit alcohol use.
History of major alcohol related complications within the preceding 2 years (liver failure/cirrhosis, pancreatitis, esophageal varices, etc.).
Has a history of atrophic rhinitis, recurrent nose bleeds, cranial surgical procedures, hypophysectomy, chronic congestion, or sinus problems.
Has a history of cardiac arrhythmia.
Clinically significant medical or psychiatric illness requiring treatment as determined by screening blood tests, medical history, and/or physical exam performed or reviewed by the study physician.
Severely low blood (< 90/50) pressure or uncontrolled high blood pressure (>160/100).
SGPT/ALT or SGOT/AST values greater than 2x upper limit of normal.
BAC level > 0.00% at the beginning of screening visit (within margin of error of detection).
Has a neurological dysfunction or psychiatric disorder (confirm with study physician).
Has a history of brain trauma (confirm with study physician).
Has an allergy or intolerance to oxytocin.
Has received an investigational drug within 30 days of Screening Visit.
Has any MRI scanning contraindications.
Has a history of claustrophobia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Mitchell, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
Berkeley
State/Province
California
ZIP/Postal Code
94720
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Oxytocin on Approach Bias and Craving
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