AlcoholismPhase 3NCT02903251
Oxytocin and Alcohol Withdrawal and Dependence
A Phase 3 study testing intranasal oxytocin spray and intranasal spray without oxytocin in people with Alcoholism and Substance-Related Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
This study evaluates the effect of oxytocin nasal spray on alcohol withdrawal and dependence in adults admitted for detoxification of alcohol, and during the following 4 weeks in an outpatient setting. Half of the participants will receive oxytocin nasal spray, the other half placebo nasal spray. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcoholism, Substance-Related Disorders
- What is being tested?
- intranasal oxytocin spray and intranasal spray without oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2016to 22 Jan 2018
- Phase
- Phase 3
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least one prior episode 2 days or longer in duration during which the subject experienced withdrawal symptoms that caused significant incapacitation (e.g., inability to work or do normal activities) OR at least one prior inpatient or outpatient medical detoxification during which the subject exhibited withdrawal symptoms of sufficient magnitude that sedative-hypnotic or anticonvulsant medication was required at least once on 2 consecutive days after cessation of or reduction in the use of alcohol following 2 weeks or more of heavy daily consumption
- average consumption of 8-30 standard drinks per day for at least 2 weeks prior to enrollment in the study;
- consenting to participate in the study;
- have residency in Trøndelag County after discharge
Who cannot join
- chronic treatment with sedative-hypnotic medications such as benzodiazepines or z-hypnotics;
- dependence on substances other than alcohol, nicotine or caffeine;
- inadequately treated, unstable and/or compromising medical or psychiatric conditions;
- low body weight (BMI < 17) or history of anorexia nervosa or bulimia in the past 2 years;
- pregnancy; parturition or breast-feeding in the past 6 months;
- inability to read well enough to complete study questionnaires determined by whether the prospective subject can read the consent form without help and correctly answer basic questions about information in the consent form;
- no alcohol in the blood and > 15 h since last intake of alcohol;
- prior inclusion and participation in the same study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute and Long-term Effects of Intranasal Oxytocin in Alcohol Withdrawal and Dependence: A Prospective Randomized Parallel Group Placebo-controlled Trial
This study evaluates the effect of oxytocin nasal spray on alcohol withdrawal and dependence in adults admitted for detoxification of alcohol, and during the following 4 weeks in an outpatient setting. Half of the participants will receive oxytocin nasal spray, the other half placebo nasal spray.
- Conditions
- Alcoholism, Substance-Related Disorders
- Being tested
- intranasal oxytocin spray, intranasal spray without oxytocin
- Keywords
- Oxytocin, Administration, Intranasal, Ethanol
- Medical subject headings
- Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intranasal oxytocin sprayDrug
Also called Syntocinon
6 insufflations (24 IU of oxytocin total) given twice daily, day 1-3. 2 insufflations (8 IU of oxytocin total) as needed, max thrice daily, day 3-30.
intranasal spray without oxytocinOther
Also called placebo
6 insufflations (24 IU of placebo total) given twice daily, day 1-3. 2 insufflations (8 IU of placebo total) as needed, max thrice daily, day 3-30.
| Study group | Role | What they receive |
|---|---|---|
| oxytocin | Experimental | intranasal oxytocin spray Day 1-3: Twice daily intranasal oxytocin spray administered by health personnel.
Day 3-30: Self-administered intranasal spray as needed, max thrice daily intranasal spray without oxytocin Receives: Drug: intranasal oxytocin spray |
| Placebo | Placebo comparator | intranasal spray without oxytocin Day 1-3: Twice daily intranasal spray without oxytocin, administered by health personnel.
Day 3-30: Self-administered intranasal spray as needed, max thrice daily Receives: Other: intranasal spray without oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total oxazepam dosage in milligrams
total oxazepam dosage per subject during detoxification, as determined by Clinical Institute Withdrawal Assessment-Alcohol, Revised (CIWA-Ar) scores
Measured: 3 days
Alcohol intake
Alcohol intake of outpatients, using blood, urine, Timeline Followback and diaries.
Measured: 30 days
Secondary outcomes (15)
Sleep
self-reported sleeping hours
Measured: 3 days
Sleep
self-reported sleeping hours
Measured: 30 days
motor activity
assessed by actigraph
Measured: 3 days
alcohol craving
self-reported using Alcohol Craving questionnaire short form revised, Norwegian version (ACQ-SF-R)
Measured: day 3
alcohol craving
self-reported using Alcohol Craving questionnaire short form revised, Norwegian version (ACQ-SF-R)
Measured: day 30
Mental distress
measured by Hopkins Symptoms Checklist 10 items (SCL-10)
Measured: day 3
Mental distress
measured by Hopkins Symptoms Checklist 10 items (SCL-10)
Measured: day 30
patient activity
measured by Patient Activity Measure 13 (PAM-13)
Measured: day 3
patient activity
measured by Patient Activity Measure 13 (PAM-13)
Measured: day 30
Socio-emotional recognition
assessed by Reading the mind in the eyes test (RMET)
Measured: Day 2
Socio-emotional recognition
assessed by Reading the mind in the eyes test (RMET)
Measured: Day 3
Socio-emotional recognition
assessed by Reading the mind in the eyes test (RMET)
Measured: day 30
Facial emotional selective attention
assessed by Visual Dot probe task
Measured: Day 2
Facial emotional selective attention
assessed by Visual Dot probe task
Measured: Day 3
Facial emotional selective attention
assessed by Visual Dot probe task
Measured: day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startOct 2016
- Primary completion22 Jan 2018
- Study completion22 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Lade Addiction Treatment Center
- Responsible party
- Sponsor
- Investigators
- Trond Jacobsen, MD PhD, Study director, St Olav's University Hospital TrondheimOlav Spigset, MD PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903251
- Sponsor's protocol ID
- 140682
- Other IDs
- 2015-004463-37, 2015
- Status last verified
- Feb 2019
- First submitted
- 30 Aug 2016
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Melby K, Grawe RW, Aamo TO, Salvesen O, Spigset O. Effect of intranasal oxytocin on alcohol withdrawal syndrome: A randomized placebo-controlled double-blind clinical trial. Drug Alcohol Depend. 2019 Apr 1;197:95-101. doi: 10.1016/j.drugalcdep.2019.01.003. Epub 2019 Feb 13.
PubMed 30784955
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Long-term Effects of Intranasal Oxytocin in Alcohol Withdrawal and Dependence: A Prospective Randomized Parallel Group Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02903251
- Acronym / sponsor ID
- 140682
- Conditions
- Alcoholism, Substance-Related Disorders
- Keywords
- Oxytocin, Administration, Intranasal, Ethanol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Lade Addiction Treatment Center
- Study start
- Oct 2016 (actual)
- Primary completion
- 22 Jan 2018 (actual)
- Study completion
- 22 Jan 2018 (actual)
- First posted
- 16 Sep 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.
This study evaluates the effect of oxytocin nasal spray on alcohol withdrawal and dependence in adults admitted for detoxification of alcohol, and during the following 4 weeks in an outpatient setting. Half of the participants will receive oxytocin nasal spray, the other half placebo nasal spray.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxytocin | Experimental | Drug: intranasal oxytocin sprayintranasal oxytocin spray Day 1-3: Twice daily intranasal oxytocin spray administered by health personnel. Day 3-30: Self-administered intranasal spray as needed, max thrice daily intranasal spray without oxytocin |
| Placebo | Placebo comparator | Other: intranasal spray without oxytocinintranasal spray without oxytocin Day 1-3: Twice daily intranasal spray without oxytocin, administered by health personnel. Day 3-30: Self-administered intranasal spray as needed, max thrice daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least one prior episode 2 days or longer in duration during which the subject experienced withdrawal symptoms that caused significant incapacitation (e.g., inability to work or do normal activities) OR at least one prior inpatient or outpatient medical detoxification during which the subject exhibited withdrawal symptoms of sufficient magnitude that sedative-hypnotic or anticonvulsant medication was required at least once on 2 consecutive days after cessation of or reduction in the use of alcohol following 2 weeks or more of heavy daily consumption
- average consumption of 8-30 standard drinks per day for at least 2 weeks prior to enrollment in the study;
- consenting to participate in the study;
- have residency in Trøndelag County after discharge
Key exclusion criteria (8 listed)
- chronic treatment with sedative-hypnotic medications such as benzodiazepines or z-hypnotics;
- dependence on substances other than alcohol, nicotine or caffeine;
- inadequately treated, unstable and/or compromising medical or psychiatric conditions;
- low body weight (BMI < 17) or history of anorexia nervosa or bulimia in the past 2 years;
- pregnancy; parturition or breast-feeding in the past 6 months;
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 |
|---|---|---|
| intranasal oxytocin sprayAlso: Syntocinon6 insufflations (24 IU of oxytocin total) given twice daily, day 1-3. 2 insufflations (8 IU of oxytocin total) as needed, max thrice daily, day 3-30. | Drug | oxytocin |
| intranasal spray without oxytocinAlso: placebo6 insufflations (24 IU of placebo total) given twice daily, day 1-3. 2 insufflations (8 IU of placebo total) as needed, max thrice daily, day 3-30. | Other | Placebo |
Primary outcome
Total oxazepam dosage in milligrams
Time frame: 3 days
total oxazepam dosage per subject during detoxification, as determined by Clinical Institute Withdrawal Assessment-Alcohol, Revised (CIWA-Ar) scores
Alcohol intake
Time frame: 30 days
Alcohol intake of outpatients, using blood, urine, Timeline Followback and diaries.
15 secondary outcomes
Sleep
Time frame: 3 days
Sleep
Time frame: 30 days
motor activity
Time frame: 3 days
alcohol craving
Time frame: day 3
alcohol craving
Time frame: day 30
Mental distress
Time frame: day 3
Mental distress
Time frame: day 30
patient activity
Time frame: day 3
patient activity
Time frame: day 30
Socio-emotional recognition
Time frame: Day 2
Socio-emotional recognition
Time frame: Day 3
Socio-emotional recognition
Time frame: day 30
Facial emotional selective attention
Time frame: Day 2
Facial emotional selective attention
Time frame: Day 3
Facial emotional selective attention
Time frame: day 30
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 26 Feb 2019.
- Results publication: PubMed 30784955Melby K, Grawe RW, Aamo TO, Salvesen O, Spigset O. Effect of intranasal oxytocin on alcohol withdrawal syndrome: A randomized placebo-controlled double-blind clinical trial. Drug Alcohol Depend. 2019 Apr 1;197:95-101. doi: 10.1016/j.drugalcdep.2019.01.003. Epub 2019 Feb 13.
- Individual participant dataSharing planned: Undecided
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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.
Trond Jacobsen, MD PhD study director
St Olav's University Hospital Trondheim
Olav Spigset, MD PhD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing intranasal oxytocin spray and intranasal spray without oxytocin in people with Alcoholism and Substance-Related Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
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 8 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 26 Feb 2019. 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 Norway. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Total oxazepam dosage in milligrams (time frame: 3 days). 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?
On the ClinicalTrials.gov record for NCT02903251, which also lists 1 linked publication.
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 26 Feb 2019.