Substance AbuseEarly Phase 1MOONCT01728909
Methadone Oxytocin Option
A Early Phase 1 study testing Oxytocin and Saline Nasal Spray in people with Substance Abuse and Opioid Dependence, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of the study is to examine the effects of intranasal oxytocin administration on social cognition in patients receiving methadone maintenance treatment (MMT), examine the effects of intranasal oxytocin administration on opioid craving and on the subjective effects of methadone, and examine the effects of… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse, Opioid Dependence, Methadone Treatment
- What is being tested?
- Oxytocin and Saline Nasal Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Oct 2014
- Phase
- Early 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary diagnosis of opioid dependence according to DSM-IV TR
- Opioid of choice be either heroin or oral opioid analgesics
- Currently be on stable dose of methadone with no dose change in the last 14 days
- -No diagnosis of mental disorder according to DSM-IV TR
Who cannot join
- Epilepsy
- Current illicit drug use (within the past one month)
- Current sever depression with suicidal thoughts and/or actions
- Addiction to alcohol or drugs other than opiates, caffeine, or nicotine
- Psychotic illness
- Bipolar disorder
Show all 13Show fewer
- Brain trauma
- Severe Neuropsychological disorder
- Kidney Disease (i.e., kidney stones, recurrent bladder infections, or known kidney failure)
- Sensitivity to preservatives (in particular E216, E218, and chlorobutanol hemihydrate)
- Nasal obstruction, discharge, or bleeding
- Cardiovascular problems (e.g., heart disease, history of heart attacks), high blood pressure (hypertension)
- Habitually drink large volumes of water
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco VA Medical Center
San Francisco, California, 94121
About this study
Official title: The Effects of Intranasal Oxytocin on Social Cognition and Social Approach Behaviors in Opioid-dependent Patients
The purpose of the study is to examine the effects of intranasal oxytocin administration on social cognition in patients receiving methadone maintenance treatment (MMT), examine the effects of intranasal oxytocin administration on opioid craving and on the subjective effects of methadone, and examine the effects of intranasal oxytocin administration on implicit preferences for drug-related and social stimuli in patients receiving MMT.
Hypothesis 1: Patients will perform better on measures of social cognition (including affect recognition and recognition of sarcasm) after administration of oxytocin compared with placebo.
Read more
Hypothesis 2: Patients will demonstrate lower craving for opioids and greater subjective effects of methadone after administration of oxytocin compared with placebo.
Hypothesis 3: Patients will demonstrate increased implicit preferences for social stimuli and decreased implicit preferences for drug related stimuli after administration of oxytocin compared with placebo.
- Conditions
- Substance Abuse, Opioid Dependence, Methadone Treatment
- Being tested
- Oxytocin, Saline Nasal Spray
- Keywords
- Oxytocin, Syntocinon, Social Cognition, Social Approach Behaviors
- Medical subject headings
- Substance-Related Disorders, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Syntocinon
40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
Saline Nasal SprayDrug
Also called Placebo
40 IU of the saline nasal spray will be administered once at the beginning of the visit.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | 40 IU Oxytocin Receives: Drug: Oxytocin |
| Saline Nasal Spray | Placebo comparator | Placebo Comparator Receives: Drug: Saline Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Computerized Social Cognition Tasks
Participants will undergo computer tasks that measure social cognition, which include the TASIT, RMET, and the IAT. The TASIT measures the awareness of social inference, the RMET measures the ability to guess the emotions of others, and the IAT measures implicit associations.
Measured: Participants will complete 2 days of the study. These 2 days will be at least a week apart.
Secondary outcomes (1)
Craving Questionnaires
Participants are asked to rate their current symptoms and current craving levels and for different substances.
Measured: Participants will complete 2 days of the study. These 2 days will be at least a week apart.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2014
- Study completionOct 2014
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 Substance AbuseStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco Veterans Affairs Medical Center
- Responsible party
- Principal investigator, Joshua Woolley, University of California, San Francisco
- Investigators
- Joshua Woolley, MD, PhD, Principal investigator, University of California San Francisco, San Francisco Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728909
- Sponsor's protocol ID
- 11-07691
- Acronym
- MOO
- Status last verified
- May 2019
- First submitted
- 7 Nov 2012
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Woolley JD, Arcuni PA, Stauffer CS, Fulford D, Carson DS, Batki S, Vinogradov S. The effects of intranasal oxytocin in opioid-dependent individuals and healthy control subjects: a pilot study. Psychopharmacology (Berl). 2016 Jul;233(13):2571-80. doi: 10.1007/s00213-016-4308-8. Epub 2016 May 3.
PubMed 27137199
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
- The Effects of Intranasal Oxytocin on Social Cognition and Social Approach Behaviors in Opioid-dependent Patients
- ClinicalTrials.gov ID
- NCT01728909
- Acronym / sponsor ID
- MOO / 11-07691
- Conditions
- Substance Abuse, Opioid Dependence, Methadone Treatment
- Keywords
- Oxytocin, Syntocinon, Social Cognition, Social Approach Behaviors
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- San Francisco Veterans Affairs Medical Center
- Study start
- May 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 Nov 2012 (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.
The purpose of the study is to examine the effects of intranasal oxytocin administration on social cognition in patients receiving methadone maintenance treatment (MMT), examine the effects of intranasal oxytocin administration on opioid craving and on the subjective effects of methadone, and examine the effects of intranasal oxytocin administration on implicit preferences for drug-related and social stimuli in patients receiving MMT.
Hypothesis 1: Patients will perform better on measures of social cognition (including affect recognition and recognition of sarcasm) after administration of oxytocin compared with placebo.
Hypothesis 2: Patients will demonstrate lower craving for opioids and greater subjective effects of methadone after administration of oxytocin compared with placebo.
Hypothesis 3: Patients will demonstrate increased implicit preferences for social stimuli and decreased implicit preferences for drug related stimuli after administration of oxytocin compared with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: Oxytocin40 IU Oxytocin |
| Saline Nasal Spray | Placebo comparator | Drug: Saline Nasal SprayPlacebo Comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary diagnosis of opioid dependence according to DSM-IV TR
- Opioid of choice be either heroin or oral opioid analgesics
- Currently be on stable dose of methadone with no dose change in the last 14 days
- -No diagnosis of mental disorder according to DSM-IV TR
Key exclusion criteria (13 listed)
- Epilepsy
- Current illicit drug use (within the past one month)
- Current sever depression with suicidal thoughts and/or actions
- Addiction to alcohol or drugs other than opiates, caffeine, or nicotine
- Psychotic illness
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 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit. | Drug | Oxytocin |
| Saline Nasal SprayAlso: Placebo40 IU of the saline nasal spray will be administered once at the beginning of the visit. | Drug | Saline Nasal Spray |
Primary outcome
Computerized Social Cognition Tasks
Time frame: Participants will complete 2 days of the study. These 2 days will be at least a week apart.
Participants will undergo computer tasks that measure social cognition, which include the TASIT, RMET, and the IAT. The TASIT measures the awareness of social inference, the RMET measures the ability to guess the emotions of others, and the IAT measures implicit associations.
1 secondary outcome
Craving Questionnaires
Time frame: Participants will complete 2 days of the study. These 2 days will be at least a week apart.
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.
- Derived from this study: PubMed 27137199Woolley JD, Arcuni PA, Stauffer CS, Fulford D, Carson DS, Batki S, Vinogradov S. The effects of intranasal oxytocin in opioid-dependent individuals and healthy control subjects: a pilot study. Psychopharmacology (Berl). 2016 Jul;233(13):2571-80. doi: 10.1007/s00213-016-4308-8. Epub 2016 May 3.
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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.
Joshua Woolley, MD, PhD principal investigator
University of California San Francisco, San Francisco Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Oxytocin and Saline Nasal Spray in people with Substance Abuse and Opioid Dependence, 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 4 inclusion and 13 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Computerized Social Cognition Tasks (time frame: Participants will complete 2 days of the study. These 2 days will be at least a week apart.). 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 NCT01728909, 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 21 May 2019.