Tobacco Use DisorderPhase 2NCT04396834
Mechanisms of Lorcaserin for Smoking Cessation
A Phase 2 study testing Lorcaserin Oral Tablet in people with Tobacco Use Disorder and Smoking Cessation, run by The Mind Research Network at 1 site in United States.
Trial summary
Identifying new medication options is critical for curbing the health burdens of cigarette smoking. Currently approved smoking cessation medications act on nicotinic receptors, and additional work is needed to identify medications with alternate pharmacological targets. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder, Smoking Cessation
- What is being tested?
- Lorcaserin Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2019to 26 Feb 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18-65
- smoking 5+ cigarettes per day (average) over the past year, with no period of abstinence > 90 days
- biochemical verification of smoking status
- at least low to moderate nicotine dependence
- reporting long-term motivation to quit smoking
- willingness to take study pills and complete study procedures
- willingness to complete lab sessions involving cigarette smoking
Who cannot join
- meeting DSM-5 criteria for substance use disorder aside from tobacco use disorder and mild cannabis use disorder
- recent (30 day) illicit drug use (except marijuana), based on self-report and urine drug screen
- past 30-day use of tobacco cessation aids or nicotine/tobacco products other than cigarettes
- past 30-day use of SSRIs, other psychiatric medications, or weight control medications
- lifetime diagnosis of severe mental illness (e.g., psychotic or bipolar I disorder)
- significant medical or neurological illness, including severe hepatic impairment or cirrhosis, or insulin dependent diabetes
Show all 15Show fewer
- actively engaged in smoking cessation treatments or a smoking cessation attempt (or intent to start an attempt in the next 90 days)
- interested in quitting smoking immediately (i.e., in the next two months)
- Medications contraindicated for use with lorcaserin or which have a significant interaction with lorcaserin
- body mass index (BMI) under normal range (BMI < 18 kg/m2)
- history of significant cardiovascular conditions including history of arrhythmias or heart block, heart failure, valvular heart disease, heart attack, stroke, unstable angina
- abnormal electrocardiogram (ECG) results
- nursing, pregnant, or anticipating pregnancy
- history of suicide attempt or recent suicidal thoughts (intent or plan) in the last month
- Plans to travel outside of the local area during the study period, or inability to commit to entire duration of study
Trial locations and contacts
1 site in 1 country.
United States1 site
The Mind Research Network
Albuquerque, New Mexico, 87106
About this study
Official title: Behavioral Mechanisms of Lorcaserin Treatment for Smoking Cessation
Identifying new medication options is critical for curbing the health burdens of cigarette smoking. Currently approved smoking cessation medications act on nicotinic receptors, and additional work is needed to identify medications with alternate pharmacological targets. Based on evidence that the serotonin system plays a role in nicotine consumption and relapse, this study will examine whether a selective serotonin medication alters smoking-related behaviors and responses to cigarette smoking under controlled conditions, informing its potential utility for smoking cessation.
Read the detailed description
Tobacco use remains the foremost cause of preventable deaths in the U.S. and worldwide. Advancing new smoking cessation therapies, including those with novel pharmacological targets, is a critical public health priority. The serotonin (5-hydroxtytryptamine; 5-HT) system is broadly implicated in the regulation of reward- related behavior, including drug seeking, in part reflecting its modulatory role in dopamine (DA) function. Recent studies show that targeted manipulation of the serotonin 5-HT2C receptor alters drug-related behavior; in particular, 5-HT2C receptor agonists are shown to reduce nicotine intake and reinstatement. Of the selective 5-HT2C receptor agonists, lorcaserin has the best near-term potential for repurposing as a smoking cessation therapy, having been approved by the U.S. Food and Drug Administration for weight management.
Preclinical findings implicate several potential behavioral mechanisms by which 5-HT2C receptor agonists might reduce drug intake, including drug-specific processes (e.g., incentive salience of drug cues, self-administration, reinstatement) and drug-nonspecific behaviors (e.g., reductions in impulsivity). To date, potential mechanisms of 5-HT2C receptor agonists have not been characterized in human studies. Given emerging interest in lorcaserin as a novel smoking cessation therapy, further studies are needed to evaluate its efficacy profile, including studies to evaluate candidate treatment mechanisms. This human laboratory investigation will examine the effects of lorcaserin vs. placebo on relapse-related outcomes using a double-blind, within-subjects, crossover design. Impulsivity subdomains will also be examined as candidate mechanisms for medication effects. By evaluating an approved 5-HT2C agonist with emergent efficacy for smoking cessation, this project has near-term potential to inform clinical applications of 5-HT2C agonists for addiction.
- Conditions
- Tobacco Use Disorder, Smoking Cessation
- Being tested
- Lorcaserin Oral Tablet, Placebo oral tablet
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lorcaserin Oral TabletDrug
Also called Belviq
Lorcasering 10mg Oral Tablet (BID)
Placebo oral tabletDrug
Also called Placebo pill
Placebo Oral Tablet (BID)
| Study group | Role | What they receive |
|---|---|---|
| Lorcaserin first, then placebo | Experimental | Participants first receive lorcaserin (10 mg BID) for 7 days. After a washout period of 7 days, they then receive placebo tablets (BID) for 7 days. Receives: Drug: Lorcaserin Oral Tablet |
| Placebo first, then lorcaserin | Experimental | Participants first receive placebo (BID) for 7 days. After a washout period of 7 days, they then receive lorcaserin (10 mg BID) for 7 days. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Lapse
Duration (in minutes) until lapsing to smoking during a 50-minute period
Measured: Laboratory session following 7 days of medication or placebo pills
Laboratory Cigarette Smoking
Number of cigarettes consumed during a 60-minute period
Measured: Laboratory session following 7 days of medication or placebo pills
Secondary outcomes (3)
Impulsivity
Performance on a behavioral measure of impulsivity, the stop signal task. Reported is the stop signal reaction time, the number of milliseconds required to activate the "stop" process in the stop signal task.
Measured: Laboratory session following 7 days of medication or placebo pills.
Reward Sensitivity
Performance on a behavioral measure of reward sensitivity (response bias measure on a signal detection task). Response bias is computed by the following equation: 1/2 * log((# correct stim 1 * # incorrect stim 2)/(# incorrect stim 1 * # correct stim 2))
Stimulus 1 is associated with a higher proportion of correct feedback than Stimulus 2, and by computing the ratio above, we are able to determine the response bias of the participant. The response bias measure provides an objective measure of reward sensitivity (i.e., the degree to which participants are biased towards choosing the more frequently rewarded response).
Measured: Laboratory session following 7 days of medication or placebo pills.
Daily Cigarette Smoking
Cigarettes smoked per day
Measured: During 7 days of medication or during 7 days of placebo pills (difference score between weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start4 Dec 2019
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
Why it stopped: Medication removed from the U.S. market by the The Food and Drug Administration
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 Tobacco Use DisorderStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Mind Research Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Hendershot, Ph.D., Principal investigator, The Mind Research NetworkEric Claus, Ph.D., Principal investigator, The Mind Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396834
- Sponsor's protocol ID
- 04619
- Status last verified
- Mar 2023
- First submitted
- 3 Feb 2020
- Last updated
- 20 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Mechanisms of Lorcaserin Treatment for Smoking Cessation
- ClinicalTrials.gov ID
- NCT04396834
- Acronym / sponsor ID
- 04619
- Conditions
- Tobacco Use Disorder, Smoking Cessation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Medication removed from the U.S. market by the The Food and Drug Administration
- Enrolment
- 3 participants (actual)
- Lead sponsor
- The Mind Research NetworkUniversity, hospital or other
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Posted 20 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Identifying new medication options is critical for curbing the health burdens of cigarette smoking. Currently approved smoking cessation medications act on nicotinic receptors, and additional work is needed to identify medications with alternate pharmacological targets. Based on evidence that the serotonin system plays a role in nicotine consumption and relapse, this study will examine whether a selective serotonin medication alters smoking-related behaviors and responses to cigarette smoking under controlled conditions, informing its potential utility for smoking cessation.
Detailed description
Tobacco use remains the foremost cause of preventable deaths in the U.S. and worldwide. Advancing new smoking cessation therapies, including those with novel pharmacological targets, is a critical public health priority. The serotonin (5-hydroxtytryptamine; 5-HT) system is broadly implicated in the regulation of reward- related behavior, including drug seeking, in part reflecting its modulatory role in dopamine (DA) function. Recent studies show that targeted manipulation of the serotonin 5-HT2C receptor alters drug-related behavior; in particular, 5-HT2C receptor agonists are shown to reduce nicotine intake and reinstatement. Of the selective 5-HT2C receptor agonists, lorcaserin has the best near-term potential for repurposing as a smoking cessation therapy, having been approved by the U.S. Food and Drug Administration for weight management.
Preclinical findings implicate several potential behavioral mechanisms by which 5-HT2C receptor agonists might reduce drug intake, including drug-specific processes (e.g., incentive salience of drug cues, self-administration, reinstatement) and drug-nonspecific behaviors (e.g., reductions in impulsivity). To date, potential mechanisms of 5-HT2C receptor agonists have not been characterized in human studies. Given emerging interest in lorcaserin as a novel smoking cessation therapy, further studies are needed to evaluate its efficacy profile, including studies to evaluate candidate treatment mechanisms. This human laboratory investigation will examine the effects of lorcaserin vs. placebo on relapse-related outcomes using a double-blind, within-subjects, crossover design. Impulsivity subdomains will also be examined as candidate mechanisms for medication effects. By evaluating an approved 5-HT2C agonist with emergent efficacy for smoking cessation, this project has near-term potential to inform clinical applications of 5-HT2C agonists for addiction.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lorcaserin first, then placebo | Experimental | Drug: Lorcaserin Oral TabletParticipants first receive lorcaserin (10 mg BID) for 7 days. After a washout period of 7 days, they then receive placebo tablets (BID) for 7 days. |
| Placebo first, then lorcaserin | Experimental | Drug: Placebo oral tabletParticipants first receive placebo (BID) for 7 days. After a washout period of 7 days, they then receive lorcaserin (10 mg BID) for 7 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age 18-65
- smoking 5+ cigarettes per day (average) over the past year, with no period of abstinence > 90 days
- biochemical verification of smoking status
- at least low to moderate nicotine dependence
- reporting long-term motivation to quit smoking
Key exclusion criteria (15 listed)
- meeting DSM-5 criteria for substance use disorder aside from tobacco use disorder and mild cannabis use disorder
- recent (30 day) illicit drug use (except marijuana), based on self-report and urine drug screen
- past 30-day use of tobacco cessation aids or nicotine/tobacco products other than cigarettes
- past 30-day use of SSRIs, other psychiatric medications, or weight control medications
- lifetime diagnosis of severe mental illness (e.g., psychotic or bipolar I 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 |
|---|---|---|
| Lorcaserin Oral TabletAlso: BelviqLorcasering 10mg Oral Tablet (BID) | Drug | Lorcaserin first, then placebo |
| Placebo oral tabletAlso: Placebo pillPlacebo Oral Tablet (BID) | Drug | Placebo first, then lorcaserin |
Primary outcome
Smoking Lapse
Time frame: Laboratory session following 7 days of medication or placebo pills
Duration (in minutes) until lapsing to smoking during a 50-minute period
Laboratory Cigarette Smoking
Time frame: Laboratory session following 7 days of medication or placebo pills
Number of cigarettes consumed during a 60-minute period
3 secondary outcomes
Impulsivity
Time frame: Laboratory session following 7 days of medication or placebo pills.
Reward Sensitivity
Time frame: Laboratory session following 7 days of medication or placebo pills.
Daily Cigarette Smoking
Time frame: During 7 days of medication or during 7 days of placebo pills (difference score between weeks).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Tobacco Use Disorder
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
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.
Christian Hendershot, Ph.D. principal investigator
The Mind Research Network
Eric Claus, Ph.D. principal investigator
The Mind Research Network
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 Oral Tablet in people with Tobacco Use Disorder and Smoking Cessation, run by The Mind Research Network 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 15 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 20 Mar 2023. 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 20 Mar 2023). 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?
Smoking Lapse (time frame: Laboratory session following 7 days of medication or placebo pills). 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 20 Mar 2023.