AlcoholismPhase 1NCT02407340
Laboratory Studies on Oxytocin for Treatment of Alcohol Use Disorder
A Phase 1 study testing oxytocin in people with Alcoholism and Alcohol Related Disorders, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study will examine the utility of the neuropeptide oxytocin (OT) as a potential new medication for the treatment of Alcohol use disorder (AUD). Non-treatment seeking men and women with AUD will be enrolled in a double blind placebo controlled phase I clinical trial. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Alcoholism, Alcohol Related Disorders
- What is being tested?
- oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 15 Jun 2017
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy 21-50 years old male and female subjects
- Must meet Diagnostic and Statistical Manual (DSM) -V criteria for AUD and not be seeking treatment
- Actively drinking
- Positive blood phosphatidylethanol (PEth) blood test
Who cannot join
- Current DSM-V major current mood or anxiety disorder or drug use disorder (excluding alcohol and nicotine use disorders, and moderate-severe cannabis use disorder); in or in need of treatment
- Drug use in last 30 days and/or positive urine toxicology screens (excluding marijuana)
- History of seizure disorder or closed head trauma
- History of withdrawal-related seizures or serious alcohol withdrawal symptoms
- HIV positive
- Neuroendocrine disorder
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- Any serious medical condition that would place subject at risk or interfere with study participation
- Liver function tests more than 3 times normal at screening
- Prescription medications in last 3 months that could affect central nervous system or HPA axis function
- Women who are pregnant, nursing or planning pregnancy cannot participate
Trial locations and contacts
1 site in 1 country.
About this study
This study will examine the utility of the neuropeptide oxytocin (OT) as a potential new medication for the treatment of Alcohol use disorder (AUD). Non-treatment seeking men and women with AUD will be enrolled in a double blind placebo controlled phase I clinical trial. Participants will complete an 7-day inpatient protocol. During the first 3 days of the inpatient protocol, participants will complete alcohol abstinence in which withdrawal symptoms are measured,and urine will be collected to determine withdrawal symptom severity and urine levels of the stress hormone cortisol. Participants will then complete 3 laboratory procedures which measure 1) stress response, 2) motivation to drink alcohol and 3) subjective and physiological effects of alcohol. Finally, because participants are individuals with AUD, investigators will administer a brief intervention to address their risky alcohol drinking and problems before discharge.
Read the detailed description
This study will lay the necessary groundwork for future comprehensive research to examine the utility of the neuropeptide oxytocin (OT) as a potential new medication for the treatment of Alcohol use disorder (AUD). OT modulates a number of key systems involved in addiction processes, including dopamine (DA) mesolimbic reward circuitry, and hypothalamic-pituitary-adrenal (HPA) axis and corticotrophin-releasing factor (CRF) stress systems, and has low abuse liability. Our overarching hypothesis is that OT will attenuate several measures thought to drive compulsive alcohol drinking and relapse. Specifically, investigators will examine whether OT decreases acute stress responses, alleviates alcohol withdrawal symptoms, reduces craving and motivation to drink, and decreases alcohol self-administration. Since interactions with alcohol are an important focus of our study, investigators will enroll non-treatment seeking heavy drinkers with AUD in a double blind, placebo controlled inpatient protocol. Subjects will be randomized to receive intranasal OT (40 IU/dose) or placebo 3 times daily. Participants will complete alcohol detoxification; investigators will measure alcohol withdrawal symptoms, craving, and 24-hr urinary free CORT. Participants will then complete 3 laboratory procedures in fixed order. The Trier Social Stress Test (TSST) which includes public speaking and performance of mental arithmetic will be used to examine subjective and physiological stress responses. An alcohol motivated responding (AMR) procedure will be used to examine subjects' responding to earn either drinks or money. A cumulative alcohol-dosing (CAD) procedure will be used to examine physiological and subjective responses across several blood alcohol levels. cortisol (CORT) levels will also be assessed. This study will provide new information on OT efficacy across a range of different measures predictive of alcohol use and misuse, and, if OT shows efficacy, help clarify the mechanism of OT action.
- Conditions
- Alcoholism, Alcohol Related Disorders
- Being tested
- oxytocin, placebo
- Keywords
- Alcohol Withdrawal Delirium
- Medical subject headings
- Alcoholism, Alcohol-Related Disorders, Alcohol Withdrawal Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxytocinDrug
Also called syntocinon
40 international Units (IU) 3xday delivered as 5 sprays (0.1 mL) per nostril
placeboDrug
Also called (Na Cl 0.65%, Phenylcarbinol, Benzalkonium Cl)
5 sprays (0.1 mL) per nostril 3xday; bottles are identical to those of active drug
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Active comparator | intranasal oxytocin - 40 International Units (IU) dose administered 3 times daily for 1 week Receives: Drug: oxytocin |
| Placebo | Placebo comparator | Intranasal placebo administered 3 times daily for 1 week Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol drinking
Group mean number of Standard Drink Units earned and self-administered in the laboratory session
Measured: 1 day
Secondary outcomes (3)
alcohol effects
Group mean stimulation and sedation subscale scores on the biphasic alcohol effects scale (BAES), a 14-item scale consisting of adjectives that describe the stimulant- and sedative-like effects of alcohol. The items are presented in alphabetical order, and are rated on an 11-point rating scale from 0=Not at All to 10=Extremely after controlled alcohol administration.
Measured: 1 day
side effects
side effects reported on the Systematic Assessment for Treatment Emergent Events (SAFTEE)
Measured: 1 week
Salivary cortisol
Peak and Area under the curve salivary cortisol levels after trier social stress test
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startMar 2015
- Primary completion15 Jun 2017
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Oxytocin vs. placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elise Weerts, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407340
- Sponsor's protocol ID
- IRB00033324
- Status last verified
- Nov 2017
- First submitted
- 30 Mar 2015
- Last updated
- 4 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laboratory Studies on Oxytocin for Treatment of Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT02407340
- Acronym / sponsor ID
- IRB00033324
- Conditions
- Alcoholism, Alcohol Related Disorders
- Keywords
- Alcohol Withdrawal Delirium
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 2 Apr 2015 (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.
This study will examine the utility of the neuropeptide oxytocin (OT) as a potential new medication for the treatment of Alcohol use disorder (AUD). Non-treatment seeking men and women with AUD will be enrolled in a double blind placebo controlled phase I clinical trial. Participants will complete an 7-day inpatient protocol. During the first 3 days of the inpatient protocol, participants will complete alcohol abstinence in which withdrawal symptoms are measured,and urine will be collected to determine withdrawal symptom severity and urine levels of the stress hormone cortisol. Participants will then complete 3 laboratory procedures which measure 1) stress response, 2) motivation to drink alcohol and 3) subjective and physiological effects of alcohol. Finally, because participants are individuals with AUD, investigators will administer a brief intervention to address their risky alcohol drinking and problems before discharge.
Detailed description
This study will lay the necessary groundwork for future comprehensive research to examine the utility of the neuropeptide oxytocin (OT) as a potential new medication for the treatment of Alcohol use disorder (AUD). OT modulates a number of key systems involved in addiction processes, including dopamine (DA) mesolimbic reward circuitry, and hypothalamic-pituitary-adrenal (HPA) axis and corticotrophin-releasing factor (CRF) stress systems, and has low abuse liability. Our overarching hypothesis is that OT will attenuate several measures thought to drive compulsive alcohol drinking and relapse. Specifically, investigators will examine whether OT decreases acute stress responses, alleviates alcohol withdrawal symptoms, reduces craving and motivation to drink, and decreases alcohol self-administration. Since interactions with alcohol are an important focus of our study, investigators will enroll non-treatment seeking heavy drinkers with AUD in a double blind, placebo controlled inpatient protocol. Subjects will be randomized to receive intranasal OT (40 IU/dose) or placebo 3 times daily. Participants will complete alcohol detoxification; investigators will measure alcohol withdrawal symptoms, craving, and 24-hr urinary free CORT. Participants will then complete 3 laboratory procedures in fixed order. The Trier Social Stress Test (TSST) which includes public speaking and performance of mental arithmetic will be used to examine subjective and physiological stress responses. An alcohol motivated responding (AMR) procedure will be used to examine subjects' responding to earn either drinks or money. A cumulative alcohol-dosing (CAD) procedure will be used to examine physiological and subjective responses across several blood alcohol levels. cortisol (CORT) levels will also be assessed. This study will provide new information on OT efficacy across a range of different measures predictive of alcohol use and misuse, and, if OT shows efficacy, help clarify the mechanism of OT action.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Oxytocin vs. placebo
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Active comparator | Drug: oxytocinintranasal oxytocin - 40 International Units (IU) dose administered 3 times daily for 1 week |
| Placebo | Placebo comparator | Drug: placeboIntranasal placebo administered 3 times daily for 1 week |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy 21-50 years old male and female subjects
- Must meet Diagnostic and Statistical Manual (DSM) -V criteria for AUD and not be seeking treatment
- Actively drinking
- Positive blood phosphatidylethanol (PEth) blood test
Key exclusion criteria (10 listed)
- Current DSM-V major current mood or anxiety disorder or drug use disorder (excluding alcohol and nicotine use disorders, and moderate-severe cannabis use disorder); in or in need of treatment
- Drug use in last 30 days and/or positive urine toxicology screens (excluding marijuana)
- History of seizure disorder or closed head trauma
- History of withdrawal-related seizures or serious alcohol withdrawal symptoms
- HIV positive
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: syntocinon40 international Units (IU) 3xday delivered as 5 sprays (0.1 mL) per nostril | Drug | Oxytocin |
| placeboAlso: (Na Cl 0.65%, Phenylcarbinol, Benzalkonium Cl)5 sprays (0.1 mL) per nostril 3xday; bottles are identical to those of active drug | Drug | Placebo |
Primary outcome
Alcohol drinking
Time frame: 1 day
Group mean number of Standard Drink Units earned and self-administered in the laboratory session
3 secondary outcomes
alcohol effects
Time frame: 1 day
side effects
Time frame: 1 week
Salivary cortisol
Time frame: 1 day
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 4 Dec 2017.
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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.
Elise Weerts, Ph.D. principal investigator
Johns Hopkins University
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 in people with Alcoholism and Alcohol Related Disorders, run by Johns Hopkins 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 4 inclusion and 10 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 4 Dec 2017. 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 drinking (time frame: 1 day). 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 4 Dec 2017.