Alcohol Use DisorderPhase 1NCT04071119
Alcohol and Cigarette Craving During Oxytocin Treatment
A Phase 1 study testing Oxytocin nasal spray in people with Alcohol Use Disorder and Smoking, run by Brown University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Alcohol Use Disorder, Smoking
- What is being tested?
- Oxytocin nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2020to 2 Apr 2024
- Phase
- Phase 1
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Alcohol and Addiction Studies
Providence, Rhode Island, 02912
About this study
Official title: The Neural Mechanisms Associated With Alcohol and Cigarette Craving in Alcohol Use Disorder Smokers During Oxytocin Treatment
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.
- Conditions
- Alcohol Use Disorder, Smoking
- Being tested
- Oxytocin nasal spray, Placebo
- Keywords
- oxytocin, craving, alcohol use disorder, smoking, cigarettes, drinking, functional magnetic resonance imaging, cue-reactivity
- Medical subject headings
- Alcoholism, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin nasal sprayDrug
Participants administer the oxytocin (40 IU) twice a day for 5 - 7 days
PlaceboDrug
Participants administer the placebo (40 IU) twice a day for 5 - 7 days
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin nasal spray | Active comparator | Not described Receives: Drug: Oxytocin nasal spray |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol craving
average alcohol craving during the cue-reactivity task
Measured: 1 day
Cigarette craving
average cigarette craving during the cue-reactivity task
Measured: 1 day
Brain activity
BOLD response when comparing alcohol to neutral cues during fMRI
Measured: 1 day
Secondary outcomes (1)
Alcohol and cigarette consumption
alcohol and cigarette consumption assessed by the Timeline Followback
Measured: 5-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start9 Nov 2020
- Primary completion2 Apr 2024
- Study completion2 Apr 2024
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.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Kimberly Goodyear, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071119
- Sponsor's protocol ID
- 22301
- Other IDs
- K01AA026874
- Status last verified
- May 2024
- First submitted
- 23 Aug 2019
- Last updated
- 14 May 2024
- 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 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neural Mechanisms Associated With Alcohol and Cigarette Craving in Alcohol Use Disorder Smokers During Oxytocin Treatment
- ClinicalTrials.gov ID
- NCT04071119
- Acronym / sponsor ID
- 22301
- Conditions
- Alcohol Use Disorder, Smoking
- Keywords
- oxytocin, craving, alcohol use disorder, smoking, cigarettes, drinking, functional magnetic resonance imaging, cue-reactivity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 28 Aug 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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin nasal spray | Active comparator | Drug: Oxytocin nasal spray |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (18 listed)
- 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
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 |
|---|---|---|
| Oxytocin nasal sprayParticipants administer the oxytocin (40 IU) twice a day for 5 - 7 days | Drug | Oxytocin nasal spray |
| PlaceboParticipants administer the placebo (40 IU) twice a day for 5 - 7 days | Drug | Placebo |
Primary outcome
Alcohol craving
Time frame: 1 day
average alcohol craving during the cue-reactivity task
Cigarette craving
Time frame: 1 day
average cigarette craving during the cue-reactivity task
Brain activity
Time frame: 1 day
BOLD response when comparing alcohol to neutral cues during fMRI
1 secondary outcome
Alcohol and cigarette consumption
Time frame: 5-7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxytocin nasal spray in people with Alcohol Use Disorder and Smoking, run by Brown University 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: finished, as of the sponsor's last update on 14 May 2024. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 craving (time frame: 1 day). The study lists 3 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 14 May 2024.