AOD Use, Abuse, and DependencePhase 4NCT01829516
Intranasal Oxytocin and Social Cognition, Implicit Preferences and Craving in Alcohol Drinkers
A Phase 4 study testing Oxytocin in people with AOD Use, Abuse, and Dependence, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a randomized, placebo controlled, double blind crossover study of the effects of intranasal oxytocin on social cognition, implicit preferences and craving in moderate to heavy social alcohol drinkers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- AOD Use, Abuse, and Dependence
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Nov 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is a volunteer between 18 and 50 years of age.
- If female, subject is non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device [IUD], hormonal birth control, or barrier method).
- Subject is able to read and speak English.
- Subject is able and willing to provide written informed consent.
- Subject is able to understand and follow the instructions of the investigator and understand all screening questionnaires.
- Subject is in good health.
Who cannot join
- Positive urine drug screen (except marijuana).
- Using cocaine, stimulants (other than nicotine and caffeine), amphetamines, hallucinogens, ecstasy, opiates, sedatives, pain pills, sleeping pills, or other psychoactive drugs within 2 weeks of the start of the study (except marijuana) OR more than 10 times in the last year (except marijuana).
- Marijuana use more than 3 times/week.
- Has a current dependence on, or addiction to any psychoactive drug (except nicotine or caffeine) including alcohol OR a recent history of substance abuse other than alcohol, tobacco or marijuana.
- Clinically significant medical or psychiatric illness requiring treatment as determined by screening blood tests, medical history, and/or physical exam performed or reviewed by the study physician.
- BAC level > 0.05% at the beginning of screening visit (within margin of error of detection).
Show all 11Show fewer
- Has a neurological dysfunction or psychiatric disorder (confirm with study physician).
- Has a history of brain trauma (confirm with study physician).
- Has an allergy or intolerance to oxytocin.
- Subject has received an investigational drug within 30 days of Screening Visit.
- Subject is considered unsuitable for the study in the opinion of the investigator, nurse practitioner, or study physician for any other reason.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ernest Gallo Clinic and Research Center
Emeryville, California, 94608
About this study
Official title: The Effects of Intranasal Oxytocin on Social Cognition, Implicit Preferences and Craving in Moderate to Heavy Social Alcohol Drinkers
This is a randomized, placebo controlled, double blind crossover study of the effects of intranasal oxytocin on social cognition, implicit preferences and craving in moderate to heavy social alcohol drinkers.
Read the detailed description
Impaired social functioning is an important feature of substance use disorders. Social deficits are a risk factor for developing substance use disorders as well as a consequence of substance abuse. Improved social functioning is also a key goal of effective substance abuse treatments. While treatment of disrupted social networks is a mainstay of psychosocial substance abuse treatments, there are currently no pharmacological interventions aimed at improving social functioning in individuals with substance use disorders. Oxytocin administration may shift preference from substance related cues to social cues and may decrease subjective craving for alcohol.
The specific aims are:
- To examine the effects of intranasal oxytocin administration on social cognition in moderate to heavy social alcohol drinkers.
- To examine the effects of intranasal oxytocin administration on alcohol craving.
- To examine the effects of intranasal oxytocin administration on implicit preferences for drug-related and social stimuli in moderate to heavy social alcohol drinkers.
- Conditions
- AOD Use, Abuse, and Dependence
- Being tested
- Oxytocin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Syntocinon
Intranasal oxytocin
PlaceboDrug
Intranasal placebo
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | 50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal oxytocin. Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | 50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal placebo.
NOTE: This is a cross-over design and subjects will participate in both arms. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Craving on the Alcohol Urge Questionnaire (AUQ) After Administration of Oxytocin vs. Placebo During the 3-week Study.
Change in craving represented by the mean difference in Alcohol Urge Questionnaire (AUQ) craving scores between alcohol and water cues (e.g., a positive alcohol-water score indicates cue-induced craving) after administration of oxytocin vs. placebo during the 3-week study. Craving for alcohol was assessed prior to the water and alcohol cues and again after each stimulus presentation using the 8-item Alcohol Urge Questionnaire (AUQ) (Bohn et al., 1995), in which subjects indicate how much they agree or disagree with statements regarding their alcohol craving on a 7-point Likert scale. AUQ craving scores are calculated by averaging responses to the 8 items. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by averaging the item scores and ranges from 1 to 7. Higher scores reflect greater craving.
Measured: Measured just prior to and after each of the water and alcohol cues at visits 2 and 3.
Secondary outcomes (1)
Average Percentage of Correct Responses on a Social Perception Task, Reading the Mind in the Eyes Test (RMET) After Administration of Oxytocin vs. Placebo During the 3-week Study.
We will examine the effects of intranasal oxytocin administration on overall RMET performance in moderate to heavy social alcohol drinkers after placebo or oxytocin administration. The RMET has 28 items. Each item is an cropped photo of a person's eyes with four emotion labels around it. The subjects are asked to select which one of the four emotion words best describes the emotion that the eyes are showing. RMET is scored by adding up the total number of correct responses (range 0-28). The mean percent correct is then calculated.
Measured: Administered at visits 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AOD Use, Abuse, and DependenceStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Mitchell, University of California, San Francisco
- Investigators
- Josh Woolley, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829516
- Sponsor's protocol ID
- Oxytocin
- Status last verified
- Jun 2016
- First submitted
- 9 Apr 2013
- Last updated
- 27 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Intranasal Oxytocin on Social Cognition, Implicit Preferences and Craving in Moderate to Heavy Social Alcohol Drinkers
- ClinicalTrials.gov ID
- NCT01829516
- Acronym / sponsor ID
- Oxytocin
- Conditions
- AOD Use, Abuse, and Dependence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 11 Apr 2013 (estimated)
- Results
- Posted 27 Jun 2016
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 randomized, placebo controlled, double blind crossover study of the effects of intranasal oxytocin on social cognition, implicit preferences and craving in moderate to heavy social alcohol drinkers.
Detailed description
Impaired social functioning is an important feature of substance use disorders. Social deficits are a risk factor for developing substance use disorders as well as a consequence of substance abuse. Improved social functioning is also a key goal of effective substance abuse treatments. While treatment of disrupted social networks is a mainstay of psychosocial substance abuse treatments, there are currently no pharmacological interventions aimed at improving social functioning in individuals with substance use disorders. Oxytocin administration may shift preference from substance related cues to social cues and may decrease subjective craving for alcohol.
The specific aims are:
- To examine the effects of intranasal oxytocin administration on social cognition in moderate to heavy social alcohol drinkers.
- To examine the effects of intranasal oxytocin administration on alcohol craving.
- To examine the effects of intranasal oxytocin administration on implicit preferences for drug-related and social stimuli in moderate to heavy social alcohol drinkers.
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: Oxytocin50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal oxytocin. |
| Placebo | Placebo comparator | Drug: Placebo50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal placebo. NOTE: This is a cross-over design and subjects will participate in both arms. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject is a volunteer between 18 and 50 years of age.
- If female, subject is non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device [IUD], hormonal birth control, or barrier method).
- Subject is able to read and speak English.
- Subject is able and willing to provide written informed consent.
- Subject is able to understand and follow the instructions of the investigator and understand all screening questionnaires.
Key exclusion criteria (11 listed)
- Positive urine drug screen (except marijuana).
- Using cocaine, stimulants (other than nicotine and caffeine), amphetamines, hallucinogens, ecstasy, opiates, sedatives, pain pills, sleeping pills, or other psychoactive drugs within 2 weeks of the start of the study (except marijuana) OR more than 10 times in the last year (except marijuana).
- Marijuana use more than 3 times/week.
- Has a current dependence on, or addiction to any psychoactive drug (except nicotine or caffeine) including alcohol OR a recent history of substance abuse other than alcohol, tobacco or marijuana.
- Clinically significant medical or psychiatric illness requiring treatment as determined by screening blood tests, medical history, and/or physical exam performed or reviewed by the study physician.
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: SyntocinonIntranasal oxytocin | Drug | Oxytocin |
| PlaceboIntranasal placebo | Drug | Placebo |
Primary outcome
Change in Craving on the Alcohol Urge Questionnaire (AUQ) After Administration of Oxytocin vs. Placebo During the 3-week Study.
Time frame: Measured just prior to and after each of the water and alcohol cues at visits 2 and 3.
Change in craving represented by the mean difference in Alcohol Urge Questionnaire (AUQ) craving scores between alcohol and water cues (e.g., a positive alcohol-water score indicates cue-induced craving) after administration of oxytocin vs. placebo during the 3-week study. Craving for alcohol was assessed prior to the water and alcohol cues and again after each stimulus presentation using the 8-item Alcohol Urge Questionnaire (AUQ) (Bohn et al., 1995), in which subjects indicate how much they agree or disagree with statements regarding their alcohol craving on a 7-point Likert scale. AUQ craving scores are calculated by averaging responses to the 8 items. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by averaging the item scores and ranges from 1 to 7. Higher scores reflect greater craving.
1 secondary outcome
Average Percentage of Correct Responses on a Social Perception Task, Reading the Mind in the Eyes Test (RMET) After Administration of Oxytocin vs. Placebo During the 3-week Study.
Time frame: Administered at visits 2 and 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Josh Woolley, MD, PhD principal investigator
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 4 study testing Oxytocin in people with AOD Use, Abuse, and 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 6 inclusion and 11 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 27 Jul 2016. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Craving on the Alcohol Urge Questionnaire (AUQ) After Administration of Oxytocin vs. Placebo During the 3-week Study. (time frame: Measured just prior to and after each of the water and alcohol cues at visits 2 and 3.). 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 27 Jul 2016.