Alcohol Use DisorderPhase 2NCT03865615
Oxytocin on Approach Bias and Craving
A Phase 2 study testing Oxytocin in people with Alcohol Use Disorder, run by Jennifer Mitchell at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 40 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 20 Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
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- 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
Who cannot join
- 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.).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
Berkeley, California, 94720
About this study
Official title: The Effects of Intranasal Oxytocin on Approach Bias and Craving in Moderate to Heavy Alcohol Drinkers
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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Oxytocin, Placebo
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Syntocinon
intranasal oxytocin 40IU/mL
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin First | Experimental | Subjects will receive oxytocin prior to their first scanning session, and placebo prior to their second scanning session. Receives: Drug: Oxytocin; Drug: Placebo |
| Placebo First | Experimental | Subjects will receive placebo prior to their first scanning session, and oxytocin prior to their second scanning session. Receives: Drug: Oxytocin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ~ 90 minutes post study drug administration
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.
Measured: ~ 90 minutes post study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start1 Nov 2023 (estimated)
- Primary completion20 Apr 2024 (estimated)
- Study completion20 Apr 2024 (estimated)
Why it stopped: COVID made study visits impossible during the funding period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Within-subject, randomized, placebo-controlled, counterbalanced, crossover design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Mitchell
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jennifer Mitchell, University of California, San Francisco
- Investigators
- Jennifer Mitchell, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865615
- Sponsor's protocol ID
- Oxytocin Approach
- Status last verified
- Jun 2022
- First submitted
- 21 Dec 2018
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Intranasal Oxytocin on Approach Bias and Craving in Moderate to Heavy Alcohol Drinkers
- ClinicalTrials.gov ID
- NCT03865615
- Acronym / sponsor ID
- Oxytocin Approach
- Conditions
- Alcohol Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID made study visits impossible during the funding period.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jennifer MitchellUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 20 Apr 2024 (estimated)
- Study completion
- 20 Apr 2024 (estimated)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Within-subject, randomized, placebo-controlled, counterbalanced, crossover design.
| Arm | Type | Receives |
|---|---|---|
| Oxytocin First | Experimental | Drug: Oxytocin, Drug: PlaceboSubjects will receive oxytocin prior to their first scanning session, and placebo prior to their second scanning session. |
| Placebo First | Experimental | Drug: Oxytocin, Drug: PlaceboSubjects will receive placebo prior to their first scanning session, and oxytocin prior to their second scanning session. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinAlso: Syntocinonintranasal oxytocin 40IU/mL | Drug | Oxytocin First, Placebo First |
| PlaceboPlacebo | Drug | Oxytocin First, Placebo First |
Primary outcome
Alcohol cue craving score
Time frame: ~ 90 minutes post study drug administration
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
Time frame: ~ 90 minutes post study drug administration
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Mitchell, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxytocin in people with Alcohol Use Disorder, run by Jennifer Mitchell at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol cue craving score (time frame: ~ 90 minutes post study drug administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2022.