AlcoholismPhase 1NCT02711189
Oxytocin in Alcohol Use Disorder
A Phase 1 study testing Oxytocin in people with Alcoholism, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
Trial summary
Background: Oxytocin is a naturally occurring substance in the body. Studies show that oxytocin may affect how the body responds to alcohol. Researchers believe oxytocin may be a possible treatment for alcoholism. Objective: To test whether the hormone oxytocin affects the brain reward system. Read more about this study
- Who is it for?
- Ages 21 to 55 years, men only
- Conditions the study is for
- Alcoholism
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 8 Mar 2016to 22 Feb 2019
- 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 21 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 21-55 year old male subjects. Justification: women will not be included due to: 1) the confound of the estrogen-modulating effect of OT; 2) the need to control for menstrual cycle phase across repeated days of study procedures which would significantly limit the feasibility of the study
- Must meet DSM-5 criteria for AUD based on the SCID
- Right handed
Who cannot join
- Non-drinkers (alcohol-naive individuals or current abstainers).
- Currently seeking treatment to reduce or stop alcohol use.
- Current diagnosis of substance use disorder other than nicotine as determined by DSM-5.
- Current clinically significant major depression or anxiety; or lifetime diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or obsessive compulsive disorder.
- Lifetime history of suicide attempts.
- Contraindications for MRI scanning, including metal in body that are contraindicated for MRI (such as implants, pacemaker, prostheses, shrapnel, irremovable piercings), left-handedness, claustrophobia or unable to lie comfortably supine for up to 2 hours in the and MRI scanner as determined from history and physician examination and the MRI safety form.
Show all 18Show fewer
- BMI>40 or if Investigators determine that subject s body shape precludes acquisition of an adequate MRI scan.
- Unable to provide a negative urine drug test (UDT).
- Medical contraindications: Current clinically significant disease, including CNS, seizures, cardiovascular, hypertension, arrhythmias, glaucoma, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders as determined by history and clinical exam at screening. Specifically, unstable hypertension, clinically significant EKG abnormalities, GFR rate > 60ml/min, liver cirrhosis, AST or ALT > 3X the upper normal limit, hemoglobin < 10.5 g/dl.
- Participants who have significant alcohol withdrawal symptoms as defined by CIWA-Ar>8.
- History of alcohol related seizures
- Requirement for or use in the past two weeks of psychoactive medications (four weeks for fluoxetine).
- Use of prescription or OTC medications known to interact with alcohol within 2 weeks of the study. These include, but may not be limited to: isosorbide, nitroglycerine, benzodiazepines, warfarin, anti-depressants such as amitriptyline, clomipramine and nefazodone, anti-diabetes medications such as glyburide, metformin and tolbutamide, H2-antagonists for heartburn such as cimetidine and ranitidine, muscle relaxants, anti-epileptics including phenytoin and phenobarbital codeine, and narcotics including darvocet, percocet and hydrocodone. Drugs known to inhibit or induce enzymes that metabolize alcohol should not be used for 4 weeks prior to the study. These include chlorzoxazone, isoniazid, metronidazole and disulfiram. Cough-and-cold preparations, which contain anti-histamines, pain medicines and anti-inflammatories such as aspirin, ibuprofen, acetaminophen, celecoxib and naproxen, should be withheld for at least 72 hours prior to each study session.
- History of hypersensitivity to oxytocin.
- Clinically significant electrolyte abnormalities, current rhinitis or use of vasoconstricting medications or prostaglandins
- Head trauma with loss of consciousness for more than 30 minutes.
- Any individuals with colorblindness that would prevent them from completing the Stroop task.
- Any other reason for which the Investigators will determine that it is not in the best interest of the participant to take part in this research.
About this study
Official title: Oxytocin in Alcohol Use Disorder: A Novel and Translational Approach
Background:
Oxytocin is a naturally occurring substance in the body. Studies show that oxytocin may affect how the body responds to alcohol. Researchers believe oxytocin may be a possible treatment for alcoholism.
Read more
Objective:
To test whether the hormone oxytocin affects the brain reward system. To see if it affects how people respond to alcohol and other rewarding things in life like food and seeing loved ones.
Eligibility:
Men ages 21-55 who have an alcohol use disorder.
Design:
Participants will have two 6-day inpatient study visits. They will have:
- Study medication or placebo given twice daily as a nasal spray.
- Height and weight measured.
- Medical history.
- Blood and urine tests.
- Breath tested for alcohol.
- Electrocardiogram.
- An alcohol administration session. In a bar-like room, where participants will consume four alcoholic drinks.
- Magnetic resonance imaging (MRI). The MRI scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder. A device called a coil will be placed over their head. Participants will complete tasks on a computer screen.
- In another alcohol session. they will drink an alcoholic beverage then answer questions. Participants will get a tab for eight more drinks ($3.00 per drink). They may drink any of the drinks or take the money. Participants will hold and smell a glass of water and their favorite alcoholic drink.
- Heart rate and blood pressure will be monitored.
- Saliva samples will be collected
- Computer tasks and questionnaires.
About one week after the end of visit 2, participants will return to clinic for a follow-up visit. Symptoms and side effects will be evaluated.
Read the detailed description
Objective:
There is compelling evidence to support that the neuropharmacology of oxytocin (OT) warrants further investigation as a potential therapeutic agent for addiction. To that end, the link between OT and dopaminergic pathways, with respect to motivated behaviors such as drug and social reward, is important to establish as a mechanism. Although preliminary clinical findings suggest a role of OT to treat withdrawal in alcoholic individuals, there is no direct human evidence on the effects of OT administration on dopamine release. Additionally, there is no direct human evidence on the effects of OT on the subjective response to alcohol. There have been no studies investigating the differential effect, if any, of OT, on the neurobehavioral response to various rewarding stimuli including alcohol, food and social reward. We propose, therefore, to investigate whether intranasal administration of OT is able to significantly reduce subjective response to alcohol, alcohol cue-induced craving and self-administration, as well as to examine the neural response to social, alcohol and food stimuli.
Study Population:
32 (24 completers) males with Alcohol Use Disorder (AUD) as defined by DSM-5 and non-treatment seekers for AUD.
Design:
A within-subject, double-blind placebo-controlled study investigating the effect of intranasal OT on the response to alcohol challenge, cue reactivity and alcohol self-administration, and the neural response to rewarding stimuli. Outcome measures: a) effect of OT on subjective response to cumulative alcohol challenge, cue reactivity and alcohol self-administration; b) neurobehavioral response to social, alcohol and food stimuli.
Outcome measures:
- effect of OT on subjective response to cumulative alcohol challenge, cue reactivity and alcohol self-administration; B) neurobehavioral response to social, alcohol and food stimuli.
- Conditions
- Alcoholism
- Being tested
- Oxytocin, Placebo
- Keywords
- Addiction, Oxytocin, Functional Magnetic Resonance Imaging (fMRI), Alcohol, Cue Reactivity
- Medical subject headings
- Alcoholism, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Oxytocin nasal spray given in dose 80
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Active comparator | Intranasal oxytocin will be delivered on twice daily basis in this crossover trial. Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | Within Subject Design Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Craving, Self-Administration
Measured: Ongoing
Stimulation Sedation; Cognitive Performance
Measured: Ongoing
BOLD response cognitive tasks and cues
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study start8 Mar 2016
- Primary completion22 Feb 2019
- Study completion22 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mary R Lee, M.D., Principal investigator, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711189
- Sponsor's protocol ID
- 160082
- Other IDs
- 16-AA-0082
- Status last verified
- 22 Feb 2019
- First submitted
- 16 Mar 2016
- Last updated
- 11 Apr 2019
- Results posted
- No
- FDA-regulated drug
- Yes
Publications
Pedersen CA, Smedley KL, Leserman J, Jarskog LF, Rau SW, Kampov-Polevoi A, Casey RL, Fender T, Garbutt JC. Intranasal oxytocin blocks alcohol withdrawal in human subjects. Alcohol Clin Exp Res. 2013 Mar;37(3):484-9. doi: 10.1111/j.1530-0277.2012.01958.x. Epub 2012 Oct 1.
PubMed 23025690McGregor IS, Bowen MT. Breaking the loop: oxytocin as a potential treatment for drug addiction. Horm Behav. 2012 Mar;61(3):331-9. doi: 10.1016/j.yhbeh.2011.12.001. Epub 2011 Dec 14.
PubMed 22198308
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxytocin in Alcohol Use Disorder: A Novel and Translational Approach
- ClinicalTrials.gov ID
- NCT02711189
- Acronym / sponsor ID
- 160082
- Conditions
- Alcoholism
- Keywords
- Addiction, Oxytocin, Functional Magnetic Resonance Imaging (fMRI), Alcohol, Cue Reactivity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- 8 Mar 2016
- Primary completion
- 22 Feb 2019 (actual)
- Study completion
- 22 Feb 2019 (actual)
- First posted
- 17 Mar 2016 (estimated)
- 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.
Background:
Oxytocin is a naturally occurring substance in the body. Studies show that oxytocin may affect how the body responds to alcohol. Researchers believe oxytocin may be a possible treatment for alcoholism.
Objective:
To test whether the hormone oxytocin affects the brain reward system. To see if it affects how people respond to alcohol and other rewarding things in life like food and seeing loved ones.
Eligibility:
Men ages 21-55 who have an alcohol use disorder.
Design:
Participants will have two 6-day inpatient study visits. They will have:
- Study medication or placebo given twice daily as a nasal spray.
- Height and weight measured.
- Medical history.
- Blood and urine tests.
- Breath tested for alcohol.
- Electrocardiogram.
- An alcohol administration session. In a bar-like room, where participants will consume four alcoholic drinks.
- Magnetic resonance imaging (MRI). The MRI scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder. A device called a coil will be placed over their head. Participants will complete tasks on a computer screen.
- In another alcohol session. they will drink an alcoholic beverage then answer questions. Participants will get a tab for eight more drinks ($3.00 per drink). They may drink any of the drinks or take the money. Participants will hold and smell a glass of water and their favorite alcoholic drink.
- Heart rate and blood pressure will be monitored.
- Saliva samples will be collected
- Computer tasks and questionnaires.
About one week after the end of visit 2, participants will return to clinic for a follow-up visit. Symptoms and side effects will be evaluated.
Detailed description
Objective:
There is compelling evidence to support that the neuropharmacology of oxytocin (OT) warrants further investigation as a potential therapeutic agent for addiction. To that end, the link between OT and dopaminergic pathways, with respect to motivated behaviors such as drug and social reward, is important to establish as a mechanism. Although preliminary clinical findings suggest a role of OT to treat withdrawal in alcoholic individuals, there is no direct human evidence on the effects of OT administration on dopamine release. Additionally, there is no direct human evidence on the effects of OT on the subjective response to alcohol. There have been no studies investigating the differential effect, if any, of OT, on the neurobehavioral response to various rewarding stimuli including alcohol, food and social reward. We propose, therefore, to investigate whether intranasal administration of OT is able to significantly reduce subjective response to alcohol, alcohol cue-induced craving and self-administration, as well as to examine the neural response to social, alcohol and food stimuli.
Study Population:
32 (24 completers) males with Alcohol Use Disorder (AUD) as defined by DSM-5 and non-treatment seekers for AUD.
Design:
A within-subject, double-blind placebo-controlled study investigating the effect of intranasal OT on the response to alcohol challenge, cue reactivity and alcohol self-administration, and the neural response to rewarding stimuli. Outcome measures: a) effect of OT on subjective response to cumulative alcohol challenge, cue reactivity and alcohol self-administration; b) neurobehavioral response to social, alcohol and food stimuli.
Outcome measures:
- effect of OT on subjective response to cumulative alcohol challenge, cue reactivity and alcohol self-administration; B) neurobehavioral response to social, alcohol and food stimuli.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Active comparator | Drug: OxytocinIntranasal oxytocin will be delivered on twice daily basis in this crossover trial. |
| Placebo | Placebo comparator | Other: PlaceboWithin Subject Design |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 21-55 year old male subjects. Justification: women will not be included due to: 1) the confound of the estrogen-modulating effect of OT; 2) the need to control for menstrual cycle phase across repeated days of study procedures which would significantly limit the feasibility of the study
- Must meet DSM-5 criteria for AUD based on the SCID
- Right handed
Key exclusion criteria (18 listed)
- Non-drinkers (alcohol-naive individuals or current abstainers).
- Currently seeking treatment to reduce or stop alcohol use.
- Current diagnosis of substance use disorder other than nicotine as determined by DSM-5.
- Current clinically significant major depression or anxiety; or lifetime diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or obsessive compulsive disorder.
- Lifetime 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 |
|---|---|---|
| OxytocinOxytocin nasal spray given in dose 80 | Drug | Oxytocin |
| Placebo | Other | Placebo |
Primary outcome
Alcohol Craving, Self-Administration
Time frame: Ongoing
Stimulation Sedation; Cognitive Performance
Time frame: Ongoing
BOLD response cognitive tasks and cues
Time frame: Ongoing
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 11 Apr 2019.
- Background: PubMed 23025690Pedersen CA, Smedley KL, Leserman J, Jarskog LF, Rau SW, Kampov-Polevoi A, Casey RL, Fender T, Garbutt JC. Intranasal oxytocin blocks alcohol withdrawal in human subjects. Alcohol Clin Exp Res. 2013 Mar;37(3):484-9. doi: 10.1111/j.1530-0277.2012.01958.x. Epub 2012 Oct 1.
- Background: PubMed 22198308McGregor IS, Bowen MT. Breaking the loop: oxytocin as a potential treatment for drug addiction. Horm Behav. 2012 Mar;61(3):331-9. doi: 10.1016/j.yhbeh.2011.12.001. Epub 2011 Dec 14.
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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.
Mary R Lee, M.D. principal investigator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxytocin in people with Alcoholism, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
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 3 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 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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 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 Craving, Self-Administration (time frame: Ongoing). 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?
On the ClinicalTrials.gov record for NCT02711189, which also lists 2 linked publications.
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 11 Apr 2019.