Smoking CessationPhase 2MIMICNCT04161144
Enhancing Self Regulation Among Smokers
A Phase 2 study testing sirolimus in people with Smoking Cessation and Smoking, Cigarette, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of rapamycin (sirolimus) versus a placebo, an inactive substance, on responses to smoking cues in individuals with nicotine dependence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Smoking, Cigarette, Nicotine Dependence
- What is being tested?
- sirolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 20 Dec 2019
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must smoke 10+ cigarettes/day for three or more years
- Have a Fagerström Test for Nicotine Dependence score greater than or equal to 4
- Be willing to make a cessation attempt
- Willing to comply with reinforced abstinence requirements for the three laboratory sessions
- Willing to use appropriate birth control methods during study participation including oral contraceptives, barrier methods (diaphragm or condoms with spermicide or both), surgical sterilization, use of an intra-uterine contraceptive device, or complete abstinence from sexual intercourse
- Remain abstinent from alcohol and all non-prescription drugs prior to medication administration and testing sessions
Show all 9Show fewer
- Live with within a 50 mile radius of our research program and have reliable transportation
- Consent to fast for a two-hour period prior to medication administration
- Consent to random assignment to rapamycin (sirolimus) vs. placebo conditions
Who cannot join
- Dependence on other substances (may meet criteria for abuse)
- Undergoing other smoking cessation treatment (e.g., nicotine replacement, Chantix)
- Taking medications that may interact with the study medication or alter responding on any study measure
- Are pregnant, nursing, or of childbearing potential and not using birth control
- Present evidence of or a history of significant endocrine, cardiovascular, pulmonary, renal or neurological disease, as these conditions may affect heart rate or skin conductance measurement
- Have significant liver impairment (as indicated by alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) values that are three times the upper limit of normal) as rapamycin (sirolimus) is hepatically metabolized
Show all 14Show fewer
- Have an existing infection or immune system disorder as rapamycin (sirolimus) has known immunosuppressive properties
- Have a history of or current psychotic disorder, severe major depression as evidenced by active and profound psychomotor retardation and/or persistent and intense suicidal ideation
- Currently taking anti-arrhythmic agents, psychostimulants or any other agents known to interfere with heart rate and skin conductance monitoring
- Have known or suspected hypersensitivity to macrolide compounds (such as rapamycin/sirolimus)
- Taking medications that could adversely interact with study medication including but not limited to significant inhibitors of CYP2D6 or CYP3A4 (voriconazole, fluconazole, itraconazole, erythromycin, clarithromycin, diltiazem, verapamil, etc.) or significant inducers of CYP3A4, such as anticonvulsants (carbamazepine, phenobarbital, phenytoin, etc.) and antibiotics (rifabutin, rifapentine, etc.)
- Have a history of thrombocytopenia, idiopathic thrombocytopenia purpura (ITP), or with a current platelet count of less than 100,000 cells per mm3,
- Have any unhealed wounds, including but not limited to oral ulcers, foot ulcers, or recent surgical or trauma wounds
- Have any planned surgeries within the next month, including surgical dental procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Enhancing Self-regulation by Altering Memories That Increase Risk of Relapse Among Smokers: A Translational Clinical Neuroscience Study of a Novel Medication
The purpose of this study is to examine the effects of rapamycin (sirolimus) versus a placebo, an inactive substance, on responses to smoking cues in individuals with nicotine dependence. Rapamycin (sirolimus) is a FDA-approved antibiotic and immunosuppressive drug that is currently used to (a) prevent organ transplant recipients from rejecting their transplants (b) treat cardiovascular diseases, and (c) treat some forms of cancer. Rapamycin (sirolimus) is not FDA-approved for smoking cessation. The use of rapamycin (sirolimus) in this study is investigational, meaning that the study medication is not a proven treatment for nicotine dependence, however this study will examine the medication's use as a potential future treatment for nicotine dependence.
Read the detailed description
The proposed study will employ 58 ND treatment-seeking smokers who will be randomly assigned to receive either 15-mg of sirolimus or placebo (group n's=29) immediately after the first of two smoking cue exposure sessions scheduled to occur on consecutive days. The first session will serve as a Retrieval session during which smoking (e.g., handling and lighting of a cigarette) cue exposure will elicit retrieval and reconsolidation of smoking-related memories; the second session will be a Test session to examine the potential modulatory role of sirolimus on the reconsolidation of memories putatively elicited during the retrieval session. Participants will be required to refrain from smoking the night before (bedtime) their first laboratory (i.e., Retrieval) session and will remain abstinent from smoking until the completion of the second laboratory (i.e., Test) session. It is posited that changes in reactivity during the test session will reflect medication effects on memory reconsolidation that occurred following the retrieval session. Measures of subjective responses (i.e., craving) and physiological reactivity (i.e., heart rate \& skin conductance) will be obtained before, during and after cue presentations in both sessions. The durability of any observed treatment effects will be assessed in a Follow-up session performed 7-days following completion of the test session. Treatment effects on self-report measures of smoking behavior during the 7-days preceding the Follow-up session will also be assessed.
- Conditions
- Smoking Cessation, Smoking, Cigarette, Nicotine Dependence
- Being tested
- sirolimus, Placebo
- Medical subject headings
- Smoking Cessation, Cigarette Smoking, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sirolimusDrug
Also called rapamycin, rapamune
Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit.
PlaceboDrug
Also called Sugar Pill
Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit.
| Study group | Role | What they receive |
|---|---|---|
| Rapamycin 15mg (sirolimus) | Active comparator | Participants will receive three 5mg pills from a nurse in the Research Nexus, some participants will receive the study medication and others will be randomized to the placebo control group. Receives: Drug: sirolimus |
| Placebo | Placebo comparator | Participants will receive three 5mg pills from a nurse in the Research Nexus, some participants will receive the study medication and others will be randomized to the placebo control group. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Craving Levels in Response to Cue
Patients are asked about craving level on a scale of 0-100, 0 is least amount of craving and 100 is highest amount of craving
Measured: Study visit 1 (Baseline; day 0), visit 2 (day 7) and visit 3 (day 14)
Heart Rate in Response to Cue
Heart rate is measured using a Biopac machine and Acqknowledge software at different timepoints throughout each visit while the participants are exposed to smoking cues.
Measured: Study visit 1 (Baseline; day 0), visit 2 (day 7) and visit 3 (day 14)
Secondary outcomes (1)
Average Cigarettes Smoked Per Day
Patients will be asked how many cigarettes per day they smoked 90 days prior to starting the study. Patients are then given a smoking and alcohol diary to complete during the course of the trial.
Measured: Visit 1 through Visit 3 (day 0-day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start1 Oct 2018
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
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 Smoking CessationStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Saladin, Ph.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161144
- Sponsor's protocol ID
- 76669
- Acronym
- MIMIC
- Status last verified
- Mar 2021
- First submitted
- 8 Nov 2019
- Last updated
- 9 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Self-regulation by Altering Memories That Increase Risk of Relapse Among Smokers: A Translational Clinical Neuroscience Study of a Novel Medication
- ClinicalTrials.gov ID
- NCT04161144
- Acronym / sponsor ID
- MIMIC / 76669
- Conditions
- Smoking Cessation, Smoking, Cigarette, Nicotine Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 13 Nov 2019 (actual)
- Results
- Posted 9 Mar 2021
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 rapamycin (sirolimus) versus a placebo, an inactive substance, on responses to smoking cues in individuals with nicotine dependence. Rapamycin (sirolimus) is a FDA-approved antibiotic and immunosuppressive drug that is currently used to (a) prevent organ transplant recipients from rejecting their transplants (b) treat cardiovascular diseases, and (c) treat some forms of cancer. Rapamycin (sirolimus) is not FDA-approved for smoking cessation. The use of rapamycin (sirolimus) in this study is investigational, meaning that the study medication is not a proven treatment for nicotine dependence, however this study will examine the medication's use as a potential future treatment for nicotine dependence.
Detailed description
The proposed study will employ 58 ND treatment-seeking smokers who will be randomly assigned to receive either 15-mg of sirolimus or placebo (group n's=29) immediately after the first of two smoking cue exposure sessions scheduled to occur on consecutive days. The first session will serve as a Retrieval session during which smoking (e.g., handling and lighting of a cigarette) cue exposure will elicit retrieval and reconsolidation of smoking-related memories; the second session will be a Test session to examine the potential modulatory role of sirolimus on the reconsolidation of memories putatively elicited during the retrieval session. Participants will be required to refrain from smoking the night before (bedtime) their first laboratory (i.e., Retrieval) session and will remain abstinent from smoking until the completion of the second laboratory (i.e., Test) session. It is posited that changes in reactivity during the test session will reflect medication effects on memory reconsolidation that occurred following the retrieval session. Measures of subjective responses (i.e., craving) and physiological reactivity (i.e., heart rate \& skin conductance) will be obtained before, during and after cue presentations in both sessions. The durability of any observed treatment effects will be assessed in a Follow-up session performed 7-days following completion of the test session. Treatment effects on self-report measures of smoking behavior during the 7-days preceding the Follow-up session will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapamycin 15mg (sirolimus) | Active comparator | Drug: sirolimusParticipants will receive three 5mg pills from a nurse in the Research Nexus, some participants will receive the study medication and others will be randomized to the placebo control group. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive three 5mg pills from a nurse in the Research Nexus, some participants will receive the study medication and others will be randomized to the placebo control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants must smoke 10+ cigarettes/day for three or more years
- Have a Fagerström Test for Nicotine Dependence score greater than or equal to 4
- Be willing to make a cessation attempt
- Willing to comply with reinforced abstinence requirements for the three laboratory sessions
- Willing to use appropriate birth control methods during study participation including oral contraceptives, barrier methods (diaphragm or condoms with spermicide or both), surgical sterilization, use of an intra-uterine contraceptive device, or complete abstinence from sexual intercourse
Key exclusion criteria (14 listed)
- Dependence on other substances (may meet criteria for abuse)
- Undergoing other smoking cessation treatment (e.g., nicotine replacement, Chantix)
- Taking medications that may interact with the study medication or alter responding on any study measure
- Are pregnant, nursing, or of childbearing potential and not using birth control
- Present evidence of or a history of significant endocrine, cardiovascular, pulmonary, renal or neurological disease, as these conditions may affect heart rate or skin conductance measurement
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 |
|---|---|---|
| sirolimusAlso: rapamycin, rapamuneRapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit. | Drug | Rapamycin 15mg (sirolimus) |
| PlaceboAlso: Sugar PillPlacebo is administered in three 5mg oral capsules. This administration happens once during the first visit. | Drug | Placebo |
Primary outcome
Craving Levels in Response to Cue
Time frame: Study visit 1 (Baseline; day 0), visit 2 (day 7) and visit 3 (day 14)
Patients are asked about craving level on a scale of 0-100, 0 is least amount of craving and 100 is highest amount of craving
Heart Rate in Response to Cue
Time frame: Study visit 1 (Baseline; day 0), visit 2 (day 7) and visit 3 (day 14)
Heart rate is measured using a Biopac machine and Acqknowledge software at different timepoints throughout each visit while the participants are exposed to smoking cues.
1 secondary outcome
Average Cigarettes Smoked Per Day
Time frame: Visit 1 through Visit 3 (day 0-day 14)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Smoking Cessation
Not yet recruiting
New Smoking Cessation Intervention in Primary Care - a Randomized Controlled Trial
Smoking Cessation, Smoking Cessation Counselling
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruiting
Contingency Management to Promote Smoking Cessation Study
Smoking Cessation
Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
Tobacco Cessation, Electronic Nicotine Delivery Systems
Recruiting
Smoking Cessation in Patients With Cancer
Cancer, Tobacco Use
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.
Michael Saladin, Ph.D. principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sirolimus in people with Smoking Cessation and Smoking, Cigarette, run by Medical University of South Carolina 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 9 inclusion and 14 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 9 Mar 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 9 Mar 2021). 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?
Craving Levels in Response to Cue (time frame: Study visit 1 (Baseline; day 0), visit 2 (day 7) and visit 3 (day 14)). 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 9 Mar 2021.