Nicotine DependencePhase 2LorNicNCT02906644
Combination Nicotine Patch / Lorcaserin for Smoking Cessation
A Phase 2 study testing lorcaserin and nicotine patch in people with Nicotine Dependence, run by Duke University at 1 site in United States.
Trial summary
This study plans to compare the efficacy of the nicotine patch / lorcaserin combination treatment vs. the nicotine patch alone in terms of leading to a reduction in smoking behavior and withdrawal symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- lorcaserin and nicotine patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2016to 18 Oct 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old;
- Smoke an average of at least 10 cigarettes per day;
- Have smoked at least one cumulative year;
- Have an expired air CO reading of at least 10ppm;
- Body weight of >50 kg (110 lbs.)
- Able to read and understand English;
- Express a desire to quit smoking in the next thirty days.
Who cannot join
- Hypertension (systolic >140 mm Hg, diastolic >100 mm Hg, coupled with a history of hypertension); subjects with no previous diagnosis of hypertension may have a screening blood pressure up to 160/100.
- Hypotension with symptoms (systolic <90 mm Hg, diastolic <60 mm Hg).
- Participants with a history of hypertension may, however, be allowed to participate in the study if the study physician or physician assistant determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual's safety.
- Coronary heart disease, diagnosed by coronary angiogram;
- Lifetime history of heart attack;
- Cardiac rhythm disorder (irregular heart rhythm);
Show all 42Show fewer
- Chest pain in the last month (unless history, exam, and ECG clearly indicate a non-cardiac source);
- Symptomatic cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
- Diagnosis of liver disease or kidney disorder (except kidney stones, gallstones);
- Gastrointestinal problems (e.g. Celiac disease, Crohn's dx Ulcerative Colitis) or disease other than gastroesophageal reflux or heartburn;
- Active ulcers in the past 30 days;
- Currently symptomatic lung disorder/disease (including but not limited to chronic obstructive pulmonary disease (COPD), emphysema, and asthma);
- Brain abnormality (including but not limited to stroke, brain tumor, and seizure disorder);
- Migraine headaches that occur more frequently than once per week;
- Recent, unexplained fainting spells;
- Problems giving blood samples;
- Diabetes (unless controlled by diet and exercise alone and screening glucose is less than 180mg/dcl and HbA1c is less than 7%);
- Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer);
- HIV, Hepatitis B, or Hepatitis C
- History of tuberculosis or recent positive purified protein derivative (PPD) test
- Other major medical condition;
- Current psychiatric disease (with the exception of anxiety disorders, obsessive compulsive disorder (OCD) and ADHD);
- Suicidal ideating (thinking about ways to commit suicide) (within the past 10 years) or lifetime occurrence of attempted suicide;
- Current depression - The Patient Health Questionnaire (PHQ-9) for Depression will be used to screen for current (within 2 weeks) depression. Potential subjects who score >9 (or who score >0 on item #9 ("Thoughts that you would be better off dead, or of hurting yourself in some way") will be excluded from study participation, and, at the discretion of the study physician, referred to appropriate psychiatric treatment;
- Bulimia or anorexia;
- BMI of < 18.5 kg/m2;
- Prior use of fenfluramine or dexfenfluramine
- Use (within the past 30 days) of:
- Illegal drugs (or if the urine drug screen is positive for tetrahydrocannabinol (THC), Cocaine, Amphetamine, Opiates, Methamphetamines, phencyclidine (PCP), Benzodiazepines, or Barbiturates), Unless recent use of prescription Opiates, Benzodiazepines for management of acute symptoms.
- Experimental (investigational) drugs;
- Psychiatric medications including antidepressants (selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs), St. John's Wort), lithium, anti-psychotics or any other medications that are known to affect smoking cessation (e.g. clonidine);
- Phentermine, triptans, tryptophan, linezolid, dextromethorphan, opiates, tramadol, or dopamine agonists;
- Any agents that have documented correlation with increased incidence of valvulopathy and/or pulmonary hypertension (e.g., cyproheptadine, trazodone, nefazodone, amoxapine, tricyclic antidepressants, mirtazapine, pergolide, ergotamine, methysergide) (or anticipated use during the study);
- Smokeless tobacco (chewing tobacco, snuff), pipes or e-cigarettes;
- Wellbutrin, bupropion, Zyban, Chantix, varenicline, nicotine patch, nicotine replacement therapy or any other smoking cessation aid.
- Concurrent use of a serotonergic agent/combination associated with severe serotonin syndrome (within the past 30 days);
- Use of cigar, cigarillos, pipe, Hookah, dissolvable nicotine, snuff, chewing tobacco more than once per month.
- Use of e-cigarettes once per month or more.
- Self-report of consuming 4 or more alcoholic drinks on 1 or more days per week;
- Significant adverse reaction to lorcaserin or nicotine patch in the past.
- Current participation or recent participation (in the past 30 days) in another smoking study at the investigators Center or another research facility.
- Current participation in another research study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Center for Smoking Cessation
Durham, North Carolina, 27705
About this study
This study plans to compare the efficacy of the nicotine patch / lorcaserin combination treatment vs. the nicotine patch alone in terms of leading to a reduction in smoking behavior and withdrawal symptoms.
Read the detailed description
This study proposes to investigate the potential efficacy of a combination of two FDA-approved agents, nicotine patch and lorcaserin, for smoking cessation treatment. The nicotine patch which provides a sustained low dose of nicotine is a nicotine receptor agonist. Lorcaserin, a serotonin 5-hydroxytryptamine receptor 2C (5-HT2C) agonist, is a drug that is FDA-approved for weight loss, and has also recently been shown to be efficacious for smoking cessation. Given that these drugs act through distinct mechanisms it is hoped that the combination will prove more efficacious than either drug alone. It is also hypothesized that the combination will reduce weight gain commonly seen after smoking cessation.
- Conditions
- Nicotine Dependence
- Being tested
- lorcaserin, nicotine patch, placebo lorcaserin
- Keywords
- Nicotine addiction, Cigarette smoking, Smoking cessation, lorcaserin, Belviq, Nicotine patches
- Medical subject headings
- Tobacco Use Disorder, Cigarette Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lorcaserinDrug
Also called Belviq
nicotine patchDrug
Also called Nicoderm
placebo lorcaserinDrug
Also called placebo Belviq
| Study group | Role | What they receive |
|---|---|---|
| Lorcaserin + Patch | Experimental | Participants will receive lorcaserin (10mg twice a day) and nicotine patches (21mg/24hr) for 14 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week. Receives: Drug: lorcaserin; Drug: nicotine patch |
| Patch | Experimental | Participants will receive nicotine patches (21mg/24hr) and placebo lorcaserin for 2 weeks; after 2 weeks participants will begin to receive active lorcaserin (10mg twice a day) along with the nicotine patches for 12 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week. Receives: Drug: lorcaserin; Drug: nicotine patch; Drug: placebo lorcaserin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-lapse
Two weeks after treatment is initiated, with nicotine patch + lorcaserin or nicotine patch alone, but still two weeks prior to the quit day, subjects will be evaluated in a modified version of the McKee Smoking Lapse Task. In this task smokers, who have been abstinent for 2 hours will be provided with the option to smoke at any time, but paid by the minute for remaining abstinent with progressively decreasing payments over an hour.
Measured: Week 2 pre quit day
Smoking Withdrawal
At the study visit above (two week post treatment initiation but 2 weeks prior to quit day), withdrawal symptoms will be assessed after 2 hours of smoking abstinence using the Shiffman-Jarvik (short form) questionnaire, which consists of 9 items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 9 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, and Arousal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.
Measured: Week 2 pre quit day
Secondary outcomes (6)
Number of Participants Reporting Smoking Abstinence
Number of participants who reported continuous four-week abstinence from smoking (weeks 7-10 post target quit date), confirmed by expired air carbon monoxide (CO).
Measured: Weeks 7-10 post quit day
Number of Participants Reporting Tolerability Issues With Lorcaserin + Nicotine Patch Treatment
Tolerability of the lorcaserin + nicotine patch treatment will be assessed by tabulating the number of participants rating side effects > "moderate".
Measured: Two Weeks pre and 10 weeks post quit day
Weight Gain Following Continuous Four-week Abstinence From Smoking
Among smoking-abstinent participants, weight gain relative to baseline will be assessed.
Measured: Week 10 post quit day
Number of Participants Reporting 6-month Smoking Abstinence
Number of participants who reported not smoking for the previous seven days when called for 6-month follow-up, confirmed by expired air carbon monoxide (CO).
Measured: 6 months post Quit Day
Percentage of Change in Ad Libitum Smoking at End of Week 2
To evaluate the effects of lorcaserin on ad libitum (ad lib) smoking, the percent change in reported number of cigarettes smoked from baseline to the end of week 2 (the day prior to the 2nd study visit) will be calculated.
Measured: Week 2 pre quit day
Adherence to Lorcaserin + Nicotine Patch Treatment as Indicator of Tolerability
Tolerability of the lorcaserin + nicotine patch treatment will be assessed by calculating adherence scores based on the percentage of days on which the study drugs were taken between visits as reported by participants on diaries.
Measured: Two Weeks pre and 10 weeks post quit day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start8 Nov 2016
- Primary completion27 Mar 2018
- Study completion18 Oct 2018
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 (2)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Jed E. Rose, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906644
- Sponsor's protocol ID
- Pro00074741
- Other IDs
- P50DA027840-06
- Acronym
- LorNic
- Status last verified
- May 2019
- First submitted
- 15 Sep 2016
- Last updated
- 7 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
PubMed 34611902Rose JE, Davis JM. Combination Lorcaserin and Nicotine Patch for Smoking Cessation Without Weight Gain. Nicotine Tob Res. 2020 Aug 24;22(9):1627-1631. doi: 10.1093/ntr/ntz149.
PubMed 31589323
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Nicotine Patch / Lorcaserin for Smoking Cessation
- ClinicalTrials.gov ID
- NCT02906644
- Acronym / sponsor ID
- LorNic / Pro00074741
- Conditions
- Nicotine Dependence
- Keywords
- Nicotine addiction, Cigarette smoking, Smoking cessation, lorcaserin, Belviq, Nicotine patches
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 8 Nov 2016 (actual)
- Primary completion
- 27 Mar 2018 (actual)
- Study completion
- 18 Oct 2018 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Posted 7 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study plans to compare the efficacy of the nicotine patch / lorcaserin combination treatment vs. the nicotine patch alone in terms of leading to a reduction in smoking behavior and withdrawal symptoms.
Detailed description
This study proposes to investigate the potential efficacy of a combination of two FDA-approved agents, nicotine patch and lorcaserin, for smoking cessation treatment. The nicotine patch which provides a sustained low dose of nicotine is a nicotine receptor agonist. Lorcaserin, a serotonin 5-hydroxytryptamine receptor 2C (5-HT2C) agonist, is a drug that is FDA-approved for weight loss, and has also recently been shown to be efficacious for smoking cessation. Given that these drugs act through distinct mechanisms it is hoped that the combination will prove more efficacious than either drug alone. It is also hypothesized that the combination will reduce weight gain commonly seen after smoking cessation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lorcaserin + Patch | Experimental | Drug: lorcaserin, Drug: nicotine patchParticipants will receive lorcaserin (10mg twice a day) and nicotine patches (21mg/24hr) for 14 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week. |
| Patch | Experimental | Drug: lorcaserin, Drug: nicotine patch, Drug: placebo lorcaserinParticipants will receive nicotine patches (21mg/24hr) and placebo lorcaserin for 2 weeks; after 2 weeks participants will begin to receive active lorcaserin (10mg twice a day) along with the nicotine patches for 12 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-65 years old;
- Smoke an average of at least 10 cigarettes per day;
- Have smoked at least one cumulative year;
- Have an expired air CO reading of at least 10ppm;
- Body weight of >50 kg (110 lbs.)
Key exclusion criteria (42 listed)
- Hypertension (systolic >140 mm Hg, diastolic >100 mm Hg, coupled with a history of hypertension); subjects with no previous diagnosis of hypertension may have a screening blood pressure up to 160/100.
- Hypotension with symptoms (systolic <90 mm Hg, diastolic <60 mm Hg).
- Participants with a history of hypertension may, however, be allowed to participate in the study if the study physician or physician assistant determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual's safety.
- Coronary heart disease, diagnosed by coronary angiogram;
- Lifetime history of heart attack;
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 |
|---|---|---|
| lorcaserinAlso: Belviq | Drug | Lorcaserin + Patch, Patch |
| nicotine patchAlso: Nicoderm | Drug | Lorcaserin + Patch, Patch |
| placebo lorcaserinAlso: placebo Belviq | Drug | Patch |
Primary outcome
Time-to-lapse
Time frame: Week 2 pre quit day
Two weeks after treatment is initiated, with nicotine patch + lorcaserin or nicotine patch alone, but still two weeks prior to the quit day, subjects will be evaluated in a modified version of the McKee Smoking Lapse Task. In this task smokers, who have been abstinent for 2 hours will be provided with the option to smoke at any time, but paid by the minute for remaining abstinent with progressively decreasing payments over an hour.
Smoking Withdrawal
Time frame: Week 2 pre quit day
At the study visit above (two week post treatment initiation but 2 weeks prior to quit day), withdrawal symptoms will be assessed after 2 hours of smoking abstinence using the Shiffman-Jarvik (short form) questionnaire, which consists of 9 items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 9 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, and Arousal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.
6 secondary outcomes
Number of Participants Reporting Smoking Abstinence
Time frame: Weeks 7-10 post quit day
Number of Participants Reporting Tolerability Issues With Lorcaserin + Nicotine Patch Treatment
Time frame: Two Weeks pre and 10 weeks post quit day
Weight Gain Following Continuous Four-week Abstinence From Smoking
Time frame: Week 10 post quit day
Number of Participants Reporting 6-month Smoking Abstinence
Time frame: 6 months post Quit Day
Percentage of Change in Ad Libitum Smoking at End of Week 2
Time frame: Week 2 pre quit day
Adherence to Lorcaserin + Nicotine Patch Treatment as Indicator of Tolerability
Time frame: Two Weeks pre and 10 weeks post quit day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34611902Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
- Derived from this study: PubMed 31589323Rose JE, Davis JM. Combination Lorcaserin and Nicotine Patch for Smoking Cessation Without Weight Gain. Nicotine Tob Res. 2020 Aug 24;22(9):1627-1631. doi: 10.1093/ntr/ntz149.
- 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.
Jed E. Rose, Ph.D. principal investigator
Duke University
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 lorcaserin and nicotine patch in people with Nicotine Dependence, run by Duke University 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 7 inclusion and 42 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 7 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. 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 7 May 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?
Time-to-lapse (time frame: Week 2 pre quit day). 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?
On the ClinicalTrials.gov record for NCT02906644, which also lists 2 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 7 May 2019.