SmokingPhase 2/3MOXYNCT03819231
Mindfulness Training Plus Oxytocin Effects on Smoking Behavior
A Phase 2/3 study testing Oxytocin, Mindfulness and Saline Solution in people with Smoking and Smoking Cessation, run by University of Southern California at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of mindfulness training and a drug called oxytocin on smoking. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Smoking, Smoking Cessation
- What is being tested?
- Oxytocin, Mindfulness and Saline Solution
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2018to 31 Dec 2023
- Phase
- Phase 2/3
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Smoke at least 10 cigarettes per day for the past year
Who cannot join
- Current DSM-5 substance use disorder
- Any medial condition that would increase risk for study participation
- Women who are pregnant or nursing
- Current use of psychiatric medication for anxiety or mood disorders
- Planning to quit or reduce smoking in the next 30 days
- Current regular use of other nicotine-containing products
- Current mindfulness or mediation practice of greater than 5 minutes per day
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033
About this study
Official title: Mindfulness Training Plus Oxytocin to Reduce Smoking and Craving Among Smokers in Withdrawal
The purpose of this study is to examine the effects of mindfulness training and a drug called oxytocin on smoking.
Read the detailed description
Mindfulness training allows individuals to be present with their own emotions, thoughts, and bodily sensations without reactive judgment, and will be given in the form of daily audio recordings. Oxytocin is a naturally occurring hormone in the brain and throughout the body. It is also an FDA-approved drug to help induce labor in pregnant women. In this study, the use oxytocin is experimental and is in the form of a nasal spray.
- Conditions
- Smoking, Smoking Cessation
- Being tested
- Oxytocin, Mindfulness, Saline Solution, Sham mindfulness
- Keywords
- Mindfulness, Oxytocin
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
A single 40 IU dose of Pitocin (oxytocin, USP; concentration = 10 IU/1 mL; PAR Pharmaceuticals, NY, USA) will be self-administered to each participant. Each 40 IU dose will be transferred into four, 1 ml intranasal atomizers and will be administered in four sprays to each nostril over the course of 15 minutes.
MindfulnessBehavioural
Participants will be instructed to listen to and practice a 20-minute guided mediation each day for 7 days prior to the experimental session. The guided mindfulness practices will include body scan and seated stillness meditations.
Saline SolutionDrug
A single 40mL doses of sterile saline (0.9% provided by USC pharmacy) will be transferred into four, 1 ml intranasal atomizers and will be self-administered in four sprays to each nostril over the course of 15 minutes.
Sham mindfulnessBehavioural
The mindfulness sham group will be required to listen to 20-minutes of Tedtalk podcasts each day that match the attention and time of the mindfulness group. Participants will be instructed to listen to two 10-minutes segments per day in succession between lab visits while in a seated posture.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness and intranasal oxytocin | Experimental | Given oxytocin through intranasal administration and self-directed mindfulness training. Receives: Drug: Oxytocin; Behavioral: Mindfulness |
| Mindfulness and placebo | Active comparator | Given sterile saline through intranasal adminstration and self-directed mindfulness training. Receives: Behavioral: Mindfulness; Drug: Saline Solution |
| Sham mindfulness and placebo | Sham comparator | Given sterile saline through intranasal adminstration and sham self-directed mindfulness training. Receives: Drug: Saline Solution; Behavioral: Sham mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Lapse Analogue Task (delay score)
This task measures ability to resist the temptation to initiate smoking under conditions in which it is advantageous to remain abstinent. The "delay score" is the number of minutes before participants begin smoking (0-50 min).
Measured: 2 hours after nasal spray administration
Trier Social Stress Test
This test measures self-reported responses to stress in a lab setting over the course of 30 minutes through salivary cortisol and heart rate variability.
Measured: 1 hour after nasal spray administration
Secondary outcomes (3)
Systolic blood pressure
Measured: Throughout study completion, an average of two weeks.
Diastolic blood pressure
Measured: Throughout study completion, an average of two weeks.
Heart rate
Measured: Throughout study completion, an average of two weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start10 Oct 2018
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Why it stopped: Study completed early due to COVID-19 pandemic regulations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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 2/3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Black, University of Southern California
- Investigators
- Matthew Kirkpatrick, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819231
- Sponsor's protocol ID
- HS-17-00972
- Acronym
- MOXY
- Status last verified
- Jun 2024
- First submitted
- 16 Jan 2019
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Training Plus Oxytocin to Reduce Smoking and Craving Among Smokers in Withdrawal
- ClinicalTrials.gov ID
- NCT03819231
- Acronym / sponsor ID
- MOXY / HS-17-00972
- Conditions
- Smoking, Smoking Cessation
- Keywords
- Mindfulness, Oxytocin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study completed early due to COVID-19 pandemic regulations.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 28 Jan 2019 (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.
The purpose of this study is to examine the effects of mindfulness training and a drug called oxytocin on smoking.
Detailed description
Mindfulness training allows individuals to be present with their own emotions, thoughts, and bodily sensations without reactive judgment, and will be given in the form of daily audio recordings. Oxytocin is a naturally occurring hormone in the brain and throughout the body. It is also an FDA-approved drug to help induce labor in pregnant women. In this study, the use oxytocin is experimental and is in the form of a nasal spray.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness and intranasal oxytocin | Experimental | Drug: Oxytocin, Behavioral: MindfulnessGiven oxytocin through intranasal administration and self-directed mindfulness training. |
| Mindfulness and placebo | Active comparator | Behavioral: Mindfulness, Drug: Saline SolutionGiven sterile saline through intranasal adminstration and self-directed mindfulness training. |
| Sham mindfulness and placebo | Sham comparator | Drug: Saline Solution, Behavioral: Sham mindfulnessGiven sterile saline through intranasal adminstration and sham self-directed mindfulness training. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Smoke at least 10 cigarettes per day for the past year
Key exclusion criteria (7 listed)
- Current DSM-5 substance use disorder
- Any medial condition that would increase risk for study participation
- Women who are pregnant or nursing
- Current use of psychiatric medication for anxiety or mood disorders
- Planning to quit or reduce smoking in the next 30 days
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 |
|---|---|---|
| OxytocinA single 40 IU dose of Pitocin (oxytocin, USP; concentration = 10 IU/1 mL; PAR Pharmaceuticals, NY, USA) will be self-administered to each participant. Each 40 IU dose will be transferred into four, 1 ml intranasal atomizers and will be administered in four sprays to each nostril over the course of 15 minutes. | Drug | Mindfulness and intranasal oxytocin |
| MindfulnessParticipants will be instructed to listen to and practice a 20-minute guided mediation each day for 7 days prior to the experimental session. The guided mindfulness practices will include body scan and seated stillness meditations. | Behavioural | Mindfulness and intranasal oxytocin, Mindfulness and placebo |
| Saline SolutionA single 40mL doses of sterile saline (0.9% provided by USC pharmacy) will be transferred into four, 1 ml intranasal atomizers and will be self-administered in four sprays to each nostril over the course of 15 minutes. | Drug | Mindfulness and placebo, Sham mindfulness and placebo |
| Sham mindfulnessThe mindfulness sham group will be required to listen to 20-minutes of Tedtalk podcasts each day that match the attention and time of the mindfulness group. Participants will be instructed to listen to two 10-minutes segments per day in succession between lab visits while in a seated posture. | Behavioural | Sham mindfulness and placebo |
Primary outcome
Smoking Lapse Analogue Task (delay score)
Time frame: 2 hours after nasal spray administration
This task measures ability to resist the temptation to initiate smoking under conditions in which it is advantageous to remain abstinent. The "delay score" is the number of minutes before participants begin smoking (0-50 min).
Trier Social Stress Test
Time frame: 1 hour after nasal spray administration
This test measures self-reported responses to stress in a lab setting over the course of 30 minutes through salivary cortisol and heart rate variability.
3 secondary outcomes
Systolic blood pressure
Time frame: Throughout study completion, an average of two weeks.
Diastolic blood pressure
Time frame: Throughout study completion, an average of two weeks.
Heart rate
Time frame: Throughout study completion, an average of two weeks.
Results and safety
The study was stopped early (reason given: Study completed early due to COVID-19 pandemic regulations.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- 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.
Matthew Kirkpatrick, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Oxytocin, Mindfulness and Saline Solution in people with Smoking and Smoking Cessation, run by University of Southern California 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 1 inclusion and 7 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: stopped early, as of the sponsor's last update on 14 Jun 2024. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Study completed early due to COVID-19 pandemic regulations.). Results are not available in the source record.
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?
Smoking Lapse Analogue Task (delay score) (time frame: 2 hours after nasal spray administration). 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?
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 14 Jun 2024.