Smoking CessationPhase 2GEMNICNCT02638597
Gemfibrozil for Nicotine Smoking Cessation
A Phase 2 study testing Gemfibrozil and smoking cessation counseling in people with Smoking Cessation, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This project will test whether gemfibrozil, a well-studied medication for high cholesterol, will help people stop smoking nicotine cigarette smoking. The study will also test whether gemfibrozil decrease cravings for cigarette and the desire to smoke. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Gemfibrozil and smoking cessation counseling
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 23 Dec 2016
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-64 years
- Meet DSM-5 criteria for tobacco use disorder based on cigarette use
- Desire to quit smoking
- Able to complete assessments and interview in English
Who cannot join
- Psychiatric co-morbidity posing safety risk, including current suicidality or psychosis as assessed on clinical interview
- Concurrent use of a statin medication (HMG-CoA reductase inhibitor),anticoagulant, or repaglinide
- Concurrent use of any FDA-approved medication for smoking cessation
- Use of any form of tobacco or nicotine (including vaporizer) other than cigarette smoking
- Any DSM-5 substance use disorder other than nicotine use disorder
- History of intolerance to any fibrate medication
Show all 10Show fewer
- History of gallbladder disease and cholestectomy has not been performed
- Baseline liver function tests > twice the upper limit of normal
- Severe impairment of renal function (baseline serum creatinine ≥ 2 mg/dL)
- Currently pregnant or nursing
Trial locations and contacts
1 site in 1 country.
About this study
This project will test whether gemfibrozil, a well-studied medication for high cholesterol, will help people stop smoking nicotine cigarette smoking. The study will also test whether gemfibrozil decrease cravings for cigarette and the desire to smoke.
Read the detailed description
This is a pilot clinical trial examining the feasibility and efficacy of gemfibrozil treatment for smoking cessation. Adults with a desire to quit nicotine cigarette smoking will be recruited. Eligible participants will be randomly divided into two groups: those who receive gemfibrozil and waitlist controls. Screening will be conducted with a brief phone screen followed by a longer screening visit for those who qualify. During the screening visit, all study participants will provide demographic information and will be interviewed regarding smoking history. Procedures performed during the screening visit include a blood draw, urine pregnancy test, physical exam, clinical psychiatric interview, and measurement of exhaled carbon monoxide (CO). At baseline, participants will complete the Heavy Smoking Index (HSI) and the Brief Questionnaire of Smoking Urges (QSU-Brief). Participants will also complete the Quick Inventory of Depressive Symptoms-Self Rated (QIDS-SR) to assess symptoms of depression and changes in mood associated with smoking cessation will be assessed with the Concise Associated Symptoms Tracking (CAST) scale . Participants will work with the research clinician to set a target quit date within one week of the baseline session, and all participants will be provided written materials with guidance for smoking cessation as part of a smoking cessation counseling session. All participants will attend visits at the research clinic at 3 days and 4 weeks from target quit date to assess safety, adherence, and smoking status; participants will also receive additional smoking cessation counseling. Smoking status will be determined with exhaled breath CO and a single item questionnaire regarding the number of cigarettes smoked since target quit date and symptoms of depression and mood changes will again be measured. Medication side effects will be quantified using the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) scale. The final study visit will occur at 8 weeks after target quit date for completion of the HSI, QIDS-SR, CAST, FIBSER, exhaled breath CO, QSU-Brief, and smoking self-report.
- Conditions
- Smoking Cessation
- Being tested
- Gemfibrozil, smoking cessation counseling
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemfibrozilDrug
Also called Lopid
FDA Approved Drug(s)/Biologic(s) (study use is not an FDA-approved use)
smoking cessation counselingBehavioural
smoking cessation counseling
| Study group | Role | What they receive |
|---|---|---|
| Gemfibrozil | Experimental | Participants in this arm will receive smoking cessation counseling and will be provided gemfibrozil 600 mg twice daily by mouth for 9 weeks, starting one week prior to target quit date and ending with study completion Receives: Drug: Gemfibrozil; Behavioral: smoking cessation counseling |
| Waitlist | Other | Participants in this arm will receive the smoking cessation counseling but will not receive medication. After completing the trial without medication, participants who continue to smoke and have a desire to quit may choose to enter the gemfibrozil arm. Receives: Behavioral: smoking cessation counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaled Carbon Monoxide (CO)
Exhaled carbon monoxide change from baseline to last available visit.
Measured: 8 weeks after target quit date
Secondary outcomes (1)
Heaviness of Smoking Index
The outcome measure was Heaviness of Smoking Index at exit. The Heaviness of Smoking Index is a two-item scale, with scores on each item rated on a 1-4 likert scale. The total score of the measure ranges from 2-8, with higher scores indicating worse outcome.
Measured: 8 weeks after target quit date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startFeb 2015
- Primary completion23 Dec 2016
- Study completion23 Dec 2016
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center
- Investigators
- Madhukar Trivedi, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638597
- Sponsor's protocol ID
- STU 072014-088
- Acronym
- GEMNIC
- Status last verified
- Jan 2019
- First submitted
- 18 Dec 2015
- Last updated
- 1 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, Markowitz JC, Ninan PT, Kornstein S, Manber R, Thase ME, Kocsis JH, Keller MB. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003 Sep 1;54(5):573-83. doi: 10.1016/s0006-3223(02)01866-8.
PubMed 12946886Trivedi MH, Wisniewski SR, Morris DW, Fava M, Kurian BT, Gollan JK, Nierenberg AA, Warden D, Gaynes BN, Luther JF, Rush AJ. Concise Associated Symptoms Tracking scale: a brief self-report and clinician rating of symptoms associated with suicidality. J Clin Psychiatry. 2011 Jun;72(6):765-74. doi: 10.4088/JCP.11m06840.
PubMed 21733477Wisniewski SR, Rush AJ, Balasubramani GK, Trivedi MH, Nierenberg AA; STARD Investigators. Self-rated global measure of the frequency, intensity, and burden of side effects. J Psychiatr Pract. 2006 Mar;12(2):71-9. doi: 10.1097/00131746-200603000-00002.
PubMed 16728903
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gemfibrozil for Nicotine Smoking Cessation
- ClinicalTrials.gov ID
- NCT02638597
- Acronym / sponsor ID
- GEMNIC / STU 072014-088
- Conditions
- Smoking Cessation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- 23 Dec 2016 (actual)
- Study completion
- 23 Dec 2016 (actual)
- First posted
- 23 Dec 2015 (estimated)
- Results
- Posted 1 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will test whether gemfibrozil, a well-studied medication for high cholesterol, will help people stop smoking nicotine cigarette smoking. The study will also test whether gemfibrozil decrease cravings for cigarette and the desire to smoke.
Detailed description
This is a pilot clinical trial examining the feasibility and efficacy of gemfibrozil treatment for smoking cessation. Adults with a desire to quit nicotine cigarette smoking will be recruited. Eligible participants will be randomly divided into two groups: those who receive gemfibrozil and waitlist controls. Screening will be conducted with a brief phone screen followed by a longer screening visit for those who qualify. During the screening visit, all study participants will provide demographic information and will be interviewed regarding smoking history. Procedures performed during the screening visit include a blood draw, urine pregnancy test, physical exam, clinical psychiatric interview, and measurement of exhaled carbon monoxide (CO). At baseline, participants will complete the Heavy Smoking Index (HSI) and the Brief Questionnaire of Smoking Urges (QSU-Brief). Participants will also complete the Quick Inventory of Depressive Symptoms-Self Rated (QIDS-SR) to assess symptoms of depression and changes in mood associated with smoking cessation will be assessed with the Concise Associated Symptoms Tracking (CAST) scale . Participants will work with the research clinician to set a target quit date within one week of the baseline session, and all participants will be provided written materials with guidance for smoking cessation as part of a smoking cessation counseling session. All participants will attend visits at the research clinic at 3 days and 4 weeks from target quit date to assess safety, adherence, and smoking status; participants will also receive additional smoking cessation counseling. Smoking status will be determined with exhaled breath CO and a single item questionnaire regarding the number of cigarettes smoked since target quit date and symptoms of depression and mood changes will again be measured. Medication side effects will be quantified using the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) scale. The final study visit will occur at 8 weeks after target quit date for completion of the HSI, QIDS-SR, CAST, FIBSER, exhaled breath CO, QSU-Brief, and smoking self-report.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemfibrozil | Experimental | Drug: Gemfibrozil, Behavioral: smoking cessation counselingParticipants in this arm will receive smoking cessation counseling and will be provided gemfibrozil 600 mg twice daily by mouth for 9 weeks, starting one week prior to target quit date and ending with study completion |
| Waitlist | Other | Behavioral: smoking cessation counselingParticipants in this arm will receive the smoking cessation counseling but will not receive medication. After completing the trial without medication, participants who continue to smoke and have a desire to quit may choose to enter the gemfibrozil arm. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-64 years
- Meet DSM-5 criteria for tobacco use disorder based on cigarette use
- Desire to quit smoking
- Able to complete assessments and interview in English
Key exclusion criteria (10 listed)
- Psychiatric co-morbidity posing safety risk, including current suicidality or psychosis as assessed on clinical interview
- Concurrent use of a statin medication (HMG-CoA reductase inhibitor),anticoagulant, or repaglinide
- Concurrent use of any FDA-approved medication for smoking cessation
- Use of any form of tobacco or nicotine (including vaporizer) other than cigarette smoking
- Any DSM-5 substance use disorder other than nicotine use disorder
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 |
|---|---|---|
| GemfibrozilAlso: LopidFDA Approved Drug(s)/Biologic(s) (study use is not an FDA-approved use) | Drug | Gemfibrozil |
| smoking cessation counselingsmoking cessation counseling | Behavioural | Gemfibrozil, Waitlist |
Primary outcome
Exhaled Carbon Monoxide (CO)
Time frame: 8 weeks after target quit date
Exhaled carbon monoxide change from baseline to last available visit.
1 secondary outcome
Heaviness of Smoking Index
Time frame: 8 weeks after target quit date
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12946886Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, Markowitz JC, Ninan PT, Kornstein S, Manber R, Thase ME, Kocsis JH, Keller MB. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003 Sep 1;54(5):573-83. doi: 10.1016/s0006-3223(02)01866-8.
- Background: PubMed 21733477Trivedi MH, Wisniewski SR, Morris DW, Fava M, Kurian BT, Gollan JK, Nierenberg AA, Warden D, Gaynes BN, Luther JF, Rush AJ. Concise Associated Symptoms Tracking scale: a brief self-report and clinician rating of symptoms associated with suicidality. J Clin Psychiatry. 2011 Jun;72(6):765-74. doi: 10.4088/JCP.11m06840.
- Background: PubMed 16728903Wisniewski SR, Rush AJ, Balasubramani GK, Trivedi MH, Nierenberg AA; STARD Investigators. Self-rated global measure of the frequency, intensity, and burden of side effects. J Psychiatr Pract. 2006 Mar;12(2):71-9. doi: 10.1097/00131746-200603000-00002.
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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.
Madhukar Trivedi, MD principal investigator
University of Texas Southwestern Medical Center
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 Gemfibrozil and smoking cessation counseling in people with Smoking Cessation, run by University of Texas Southwestern Medical Center 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 10 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 1 Feb 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. 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 1 Feb 2019). 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?
Exhaled Carbon Monoxide (CO) (time frame: 8 weeks after target quit date). 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 NCT02638597, which also lists 3 linked publications.
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 1 Feb 2019.