AlcoholismPhase 3NCT03339024
Intranasal Oxytocin Effects in Alcohol Withdrawal and Dependence; Follow-up Study
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 is an assessment of the long-term effect of oxytocin nasal spray on alcohol withdrawal and dependence in adults admitted for detoxification of alcohol after 60 days and 1 year. 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
- 38 participants
- Where
- 1 siteNorway
- Study dates
- 1 Nov 2017to 31 Mar 2019
- 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
- participants in the RCT (NCT02903251) who completed the study
Who cannot join
- participants in the RCT (NCT02903251) who did not complete the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Effects of Intranasal Oxytocin in Alcohol Withdrawal and Dependence: Follow-up of a Randomized Controlled Trial
This study is an assessment of the long-term effect of oxytocin nasal spray on alcohol withdrawal and dependence in adults admitted for detoxification of alcohol after 60 days and 1 year. It is a follow-up study of a placebo-controlled randomized controlled study where subjects used oxytocin nasal spray during acute withdrawal and the following 4 weeks in an outpatient setting. Half of the participants have received oxytocin nasal spray, the other half placebo nasal spray (NCT02903251). (added March 2019: 24 patients were available for 1-year follow-up)
- Conditions
- Alcoholism, Substance-Related Disorders
- Being tested
- intranasal oxytocin spray, intranasal spray without oxytocin
- Keywords
- Oxytocin, Administration, Intranasal, Ethanol, Follow-up Studies
- 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 Day 30 - 12 months: No further oxytocin treatment, i.e. treatment-as-usual.
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 Day 30 - 12 months: No further oxytocin treatment, i.e. treatment-as-usual.
| 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 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.
Alcohol intake
using self-reported alcohol use (days used and alcohol units)
Measured: 60 days
Alcohol intake
using the Timeline Follow-back method and phosphatidylethanol (PEth) blood test
Measured: 1 year
Secondary outcomes (3)
Sleep
self-reported sleeping hours
Measured: 60 days
Sleep
self-reported sleeping hours
Measured: 1 year
Number of rehospitalisations and readmissions to treatment for substance use disorders
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start1 Nov 2017
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
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
- 38 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
- Olav Spigset, MD PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339024
- Sponsor's protocol ID
- 2016/45
- Other IDs
- 2015-004463-37, 2015
- Status last verified
- Feb 2020
- First submitted
- 7 Nov 2017
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Melby K, Fasmer OB, Henriksen TE, Grawe RW, Aamo TO, Spigset O. Actigraphy assessment of motor activity and sleep in patients with alcohol withdrawal syndrome and the effects of intranasal oxytocin. PLoS One. 2020 Feb 13;15(2):e0228700. doi: 10.1371/journal.pone.0228700. eCollection 2020.
PubMed 32053696
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of Intranasal Oxytocin in Alcohol Withdrawal and Dependence: Follow-up of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03339024
- Acronym / sponsor ID
- 2016/45
- Conditions
- Alcoholism, Substance-Related Disorders
- Keywords
- Oxytocin, Administration, Intranasal, Ethanol, Follow-up Studies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Lade Addiction Treatment Center
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 9 Nov 2017 (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 study is an assessment of the long-term effect of oxytocin nasal spray on alcohol withdrawal and dependence in adults admitted for detoxification of alcohol after 60 days and 1 year. It is a follow-up study of a placebo-controlled randomized controlled study where subjects used oxytocin nasal spray during acute withdrawal and the following 4 weeks in an outpatient setting. Half of the participants have received oxytocin nasal spray, the other half placebo nasal spray (NCT02903251). (added March 2019: 24 patients were available for 1-year follow-up)
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 |
| 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 (1 listed)
- participants in the RCT (NCT02903251) who completed the study
Key exclusion criteria (1 listed)
- participants in the RCT (NCT02903251) who did not complete the study
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 Day 30 - 12 months: No further oxytocin treatment, i.e. treatment-as-usual. | 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 Day 30 - 12 months: No further oxytocin treatment, i.e. treatment-as-usual. | Other | Placebo |
Primary outcome
Alcohol intake
Time frame: 60 days
using self-reported alcohol use (days used and alcohol units)
Alcohol intake
Time frame: 1 year
using the Timeline Follow-back method and phosphatidylethanol (PEth) blood test
3 secondary outcomes
Sleep
Time frame: 60 days
Sleep
Time frame: 1 year
Number of rehospitalisations and readmissions to treatment for substance use disorders
Time frame: 1 year
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 19 Feb 2020.
- Results publication: PubMed 32053696Melby K, Fasmer OB, Henriksen TE, Grawe RW, Aamo TO, Spigset O. Actigraphy assessment of motor activity and sleep in patients with alcohol withdrawal syndrome and the effects of intranasal oxytocin. PLoS One. 2020 Feb 13;15(2):e0228700. doi: 10.1371/journal.pone.0228700. eCollection 2020.
- 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.
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 1 inclusion and 1 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 19 Feb 2020. 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?
Alcohol intake (time frame: 60 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 NCT03339024, 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 19 Feb 2020.