Opioid Use DisorderPhase 1COOOLNCT02028533
Cocaine Opioid Oxytocin Option - Limited
A Phase 1 study testing Oxytocin in people with Opioid Use Disorder and Cocaine Use Disorder, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a pilot feasibility study assessing the tolerability of chronic administration of intranasal oxytocin to patients receiving methadone at an opioid replacement clinic who are actively using cocaine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Cocaine Use Disorder
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Dec 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolled as a patient in the San Francisco General Hospital Opioid Treatment Outpatient Program
- Stable dose of methadone for at least the past two weeks
- At least one routine urine toxicology screen positive for cocaine in the past month
Who cannot join
- Positive urine pregnancy test
- Use of illicit drugs in the past month (with the exception of cocaine or cannabis)
- Currently meets Diagnostic and Statistical Manual-5 (DSM-V) criteria for severe major depressive disorder with suicidal thoughts or actions
- History of psychotic or moderate-severe alcohol use disorder as defined by DSM-V criteria
- Severe neuropsychological disorder, brain trauma, epilepsy
- Sensitivity to preservatives (in particular E 216, E 218 and chlorobutanol hemihydrate)
Show all 9Show fewer
- Nasal obstruction, discharge, or bleeding
- Habitually drinks large volumes of water
- Taking testosterone, estrogen/progesterone supplement, or serotonin-1a receptor agonists/antagonists
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hospital Opiate Treatment Outpatient Program
San Francisco, California, 94110
About this study
Official title: Chronic Intranasal Oxytocin as an Adjunct to Methadone Maintenance Treatment in Patients With Co-occuring Opioid Use Disorder and Cocaine Use: A 2-week Pilot Study
This is a pilot feasibility study assessing the tolerability of chronic administration of intranasal oxytocin to patients receiving methadone at an opioid replacement clinic who are actively using cocaine.
- Conditions
- Opioid Use Disorder, Cocaine Use Disorder
- Being tested
- Oxytocin, Placebo
- Keywords
- addiction, oxytocin, tolerability
- Medical subject headings
- Opioid-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called oxytocin nasal spray, Syntocinon
PlaceboDrug
Also called placebo nasal spray
| Study group | Role | What they receive |
|---|---|---|
| Patients 1 | Active comparator | Participants will receive intranasal oxytocin 40 International Units (IU). Receives: Drug: Oxytocin |
| Patients 2 | Placebo comparator | Participants will receive 40 International Units of intranasal placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with non-serious and serious adverse events
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Woolley, University of California, San Francisco
- Investigators
- Christopher S Stauffer, MD, Principal investigator, University of California, San FranciscoJoshua Woolley, MD, PhD, Study director, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028533
- Sponsor's protocol ID
- 13-12534
- Acronym
- COOOL
- Status last verified
- May 2019
- First submitted
- 3 Jan 2014
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Intranasal Oxytocin as an Adjunct to Methadone Maintenance Treatment in Patients With Co-occuring Opioid Use Disorder and Cocaine Use: A 2-week Pilot Study
- ClinicalTrials.gov ID
- NCT02028533
- Acronym / sponsor ID
- COOOL / 13-12534
- Conditions
- Opioid Use Disorder, Cocaine Use Disorder
- Keywords
- addiction, oxytocin, tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 Jan 2014 (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 is a pilot feasibility study assessing the tolerability of chronic administration of intranasal oxytocin to patients receiving methadone at an opioid replacement clinic who are actively using cocaine.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients 1 | Active comparator | Drug: OxytocinParticipants will receive intranasal oxytocin 40 International Units (IU). |
| Patients 2 | Placebo comparator | Drug: PlaceboParticipants will receive 40 International Units of intranasal placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Enrolled as a patient in the San Francisco General Hospital Opioid Treatment Outpatient Program
- Stable dose of methadone for at least the past two weeks
- At least one routine urine toxicology screen positive for cocaine in the past month
Key exclusion criteria (9 listed)
- Positive urine pregnancy test
- Use of illicit drugs in the past month (with the exception of cocaine or cannabis)
- Currently meets Diagnostic and Statistical Manual-5 (DSM-V) criteria for severe major depressive disorder with suicidal thoughts or actions
- History of psychotic or moderate-severe alcohol use disorder as defined by DSM-V criteria
- Severe neuropsychological disorder, brain trauma, epilepsy
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: oxytocin nasal spray, Syntocinon | Drug | Patients 1 |
| PlaceboAlso: placebo nasal spray | Drug | Patients 2 |
Primary outcome
Number of patients with non-serious and serious adverse events
Time frame: 3 weeks
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 21 May 2019.
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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.
Christopher S Stauffer, MD principal investigator
University of California, San Francisco
Joshua Woolley, MD, PhD study director
University of California, San Francisco
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 Opioid Use Disorder and Cocaine Use Disorder, run by University of California, San Francisco 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 3 inclusion and 9 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 21 May 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 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?
Number of patients with non-serious and serious adverse events (time frame: 3 weeks). 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 21 May 2019.