Alcohol Use DisorderPhase 2NCT04396847
Laboratory Screening of Lorcaserin for Alcohol Use Disorder
A Phase 2 study testing Lorcaserin Oral Tablet in people with Alcohol Use Disorder and Tobacco Smoking, run by The Mind Research Network at 1 site in United States.
Trial summary
Heavy-drinking smokers, including those with alcohol use disorder (AUD), are at increased risk for numerous negative health outcomes relative to those who use alcohol or cigarettes only. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder, Tobacco Smoking
- 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
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 21-65
- Meeting DSM-5 criteria for current (past year) AUD, as well as current at-risk drinking (i.e., ≥14/21 drinks per week for women/men, on average), with at least four episodes of 4+/5+ drinks in the past 30 days
- Daily smoker, defined as reporting smoking 1+ cigarettes per day, on average, over the past 12 months
- Willingness to take study pills and complete study procedures
- Willingness to complete lab sessions involving alcohol administration
Who cannot join
- Recent (30 day) illicit drug use (with the exception of cannabis) based on self-report or toxicology screen
- Meeting DSM-5 criteria for a past-year substance use disorder other than alcohol use disorder, tobacco use disorder, or mild cannabis use disorder
- Significant alcohol withdrawal, based on a Clinical Institute Withdrawal Assessment for Alcohol-revised (CIWA-Ar) score of 8+ at baseline medical visit, or any reported history of severe withdrawal symptoms (e.g., seizures)
- Past 30-day use of nicotine replacement
- 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)
Show all 15Show fewer
- Significant medical or neurological illness based on medical staff (i.e., physician or nurse practitioner) evaluation including severe hepatic impairment or cirrhosis, insulin dependent diabetes
- Current alcohol or smoking cessation treatment or efforts to cut down on drinking/smoking
- Medications contraindicated for use with lorcaserin or which have a significant interaction with lorcaserin
- Body mass index (BMI) under normal range (<18kg/m2)
- History of significant cardiovascular conditions including history of arrhythmias or heart block, heart failure, valvular heart disease, heat attack, stroke, unstable angina
- Abnormal electrocardiogram (ECG) results
- Currently nursing, pregnant, or anticipating pregnancy
- history of suicide attempt or recent suicidal ideation (i.e., 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: Human Laboratory Screening of Lorcaserin in Smokers With Alcohol Use Disorder
Heavy-drinking smokers, including those with alcohol use disorder (AUD), are at increased risk for numerous negative health outcomes relative to those who use alcohol or cigarettes only. Although heavy-drinking smokers are recognized as an important subgroup for clinical and public health interventions, there are presently no approved medications for the joint indication of alcohol reduction and smoking cessation. Based on evidence that the serotonin system plays a role in alcohol and nicotine consumption and relapse, this study aims to examine whether a serotonin medication alters alcohol and nicotine responses in smokers with AUD, informing its potential utility as a candidate therapy for this clinical subgroup.
Read the detailed description
Pharmacotherapy development remains a critical objective for reducing health and societal burdens associated with alcohol use disorder (AUD). Developing targeted treatments for specific AUD subgroups is a key objective. Among those with AUD, cigarette smokers comprise a sizable and critical subgroup with disproportionally high long-term health risks, making it a key priority to advance therapies for concurrent AUD and cigarette smoking. The serotonin (5-hydroxtytryptamine; 5-HT) system is broadly implicated in addictive behaviors, in part reflecting the role of 5-HT in modulating dopamine function. Preclinical studies of 5-HT receptor drugs have shown that targeted modulation of the 5-HT2C receptor (implicated in 5-HT-related inhibition of DA function) alters the consumption and reinstatement of addictive drugs, including alcohol and nicotine. Of the selective 5-HT2C receptor agonists, lorcaserin has superior near-term potential for repurposing as an AUD therapy, having been approved by the Food and Drug Administration for weight management. Human laboratory medication trials offer a time- and cost-effective option for validating preclinical findings prior to larger randomized controlled trials, and for testing candidate treatment mechanisms. This Phase II human laboratory screening trial will evaluate lorcaserin as a novel candidate therapy for smokers with AUD. Effects of lorcaserin vs. placebo will be evaluated in a double-blind, within-subjects, crossover study with human laboratory endpoints. This study will provide early human data on the effects of a 5-HT2C receptor agonist in relation to alcohol-related outcomes, informing its potential for further evaluation as a candidate treatment for AUD.
- Conditions
- Alcohol Use Disorder, Tobacco Smoking
- Being tested
- Lorcaserin Oral Tablet, Placebo oral tablet
- Medical subject headings
- Alcoholism, Tobacco Smoking
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 | Placebo comparator | 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.
Laboratory Alcohol Consumption
Number of drinks consumed during a 2-hour alcohol self-administration session
Measured: Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pills.
Secondary outcomes (5)
Subjective Responses to Alcohol
Maximum self-reported stimulation during alcohol self-administration, as measured by the Brief Biphasic Alcohol Effects Scale. The final reported score is the sum of each item in the stimulation scale divided by the total number of items (3). The range of scores is 0-10, with higher numbers indicating higher subjective stimulation from alcohol.
Measured: Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pills
Motivation to Consume Alcohol
Self-reported alcohol demand, as measured by elasticity in the Alcohol Purchase Task. Elasticity was computed according to Jacobs \& Bickel (1999), using the estimated parameters a and b from the equation ln C = ln L + b(ln P) - aP, where C is number of drinks that would be consumed at price P, and L is a constant that represents the number of drinks consumed at P = 1. Overall elasticity is determined by computing elasticity (a-b(P)) for each price/consumption pair and taking the mean. Greater values of elasticity (i.e., less negative in this case) indicate increased willingness to consume the same number of drinks even as the price increases.
Measured: Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pills.
Motivation to Smoke Cigarettes
Self-reported cigarette demand, as measured by elasticity in the Cigarette Purchase Task. Elasticity was computed according to Jacobs \& Bickel (1999), using the estimated parameters a and b from the equation ln C = ln L + b(ln P) - aP, where C is number of cigarettes that would be purchased at price P, and L is a constant that represents the number of cigarettes purchased at P = 1. Overall elasticity is determined by computing elasticity (a-b(P)) for each price/consumption pair and taking the mean. Greater values of elasticity (i.e., less negative in this case) indicate increased willingness to purchase the same number of cigarettes even as the price increases.
Measured: Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pills.
Daily Alcohol Consumption
Self-reported drinks per drinking day
Measured: During 7 days of medication or during 7 days of placebo pills.
Cigarette Consumption
Number of cigarettes smoked per day
Measured: During 7 days of medication or during 7 days of placebo pills.
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 start25 Oct 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 Alcohol 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
- 5 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
- NCT04396847
- Sponsor's protocol ID
- 04719
- Status last verified
- Aug 2022
- First submitted
- 3 Feb 2020
- Last updated
- 7 Sep 2022
- 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 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Laboratory Screening of Lorcaserin in Smokers With Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT04396847
- Acronym / sponsor ID
- 04719
- Conditions
- Alcohol Use Disorder, Tobacco Smoking
- 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
- 5 participants (actual)
- Lead sponsor
- The Mind Research NetworkUniversity, hospital or other
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Posted 7 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heavy-drinking smokers, including those with alcohol use disorder (AUD), are at increased risk for numerous negative health outcomes relative to those who use alcohol or cigarettes only. Although heavy-drinking smokers are recognized as an important subgroup for clinical and public health interventions, there are presently no approved medications for the joint indication of alcohol reduction and smoking cessation. Based on evidence that the serotonin system plays a role in alcohol and nicotine consumption and relapse, this study aims to examine whether a serotonin medication alters alcohol and nicotine responses in smokers with AUD, informing its potential utility as a candidate therapy for this clinical subgroup.
Detailed description
Pharmacotherapy development remains a critical objective for reducing health and societal burdens associated with alcohol use disorder (AUD). Developing targeted treatments for specific AUD subgroups is a key objective. Among those with AUD, cigarette smokers comprise a sizable and critical subgroup with disproportionally high long-term health risks, making it a key priority to advance therapies for concurrent AUD and cigarette smoking. The serotonin (5-hydroxtytryptamine; 5-HT) system is broadly implicated in addictive behaviors, in part reflecting the role of 5-HT in modulating dopamine function. Preclinical studies of 5-HT receptor drugs have shown that targeted modulation of the 5-HT2C receptor (implicated in 5-HT-related inhibition of DA function) alters the consumption and reinstatement of addictive drugs, including alcohol and nicotine. Of the selective 5-HT2C receptor agonists, lorcaserin has superior near-term potential for repurposing as an AUD therapy, having been approved by the Food and Drug Administration for weight management. Human laboratory medication trials offer a time- and cost-effective option for validating preclinical findings prior to larger randomized controlled trials, and for testing candidate treatment mechanisms. This Phase II human laboratory screening trial will evaluate lorcaserin as a novel candidate therapy for smokers with AUD. Effects of lorcaserin vs. placebo will be evaluated in a double-blind, within-subjects, crossover study with human laboratory endpoints. This study will provide early human data on the effects of a 5-HT2C receptor agonist in relation to alcohol-related outcomes, informing its potential for further evaluation as a candidate treatment for AUD.
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 | Placebo comparator | 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
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 21-65
- Meeting DSM-5 criteria for current (past year) AUD, as well as current at-risk drinking (i.e., ≥14/21 drinks per week for women/men, on average), with at least four episodes of 4+/5+ drinks in the past 30 days
- Daily smoker, defined as reporting smoking 1+ cigarettes per day, on average, over the past 12 months
- Willingness to take study pills and complete study procedures
- Willingness to complete lab sessions involving alcohol administration
Key exclusion criteria (15 listed)
- Recent (30 day) illicit drug use (with the exception of cannabis) based on self-report or toxicology screen
- Meeting DSM-5 criteria for a past-year substance use disorder other than alcohol use disorder, tobacco use disorder, or mild cannabis use disorder
- Significant alcohol withdrawal, based on a Clinical Institute Withdrawal Assessment for Alcohol-revised (CIWA-Ar) score of 8+ at baseline medical visit, or any reported history of severe withdrawal symptoms (e.g., seizures)
- Past 30-day use of nicotine replacement
- Past 30-day use of SSRIs, other psychiatric medications, or weight control medications
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
Laboratory Alcohol Consumption
Time frame: Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pills.
Number of drinks consumed during a 2-hour alcohol self-administration session
5 secondary outcomes
Subjective Responses to Alcohol
Time frame: Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pills
Motivation to Consume Alcohol
Time frame: Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pills.
Motivation to Smoke Cigarettes
Time frame: Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pills.
Daily Alcohol Consumption
Time frame: During 7 days of medication or during 7 days of placebo pills.
Cigarette Consumption
Time frame: During 7 days of medication or during 7 days of placebo pills.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Alcohol Use Disorder
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
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 Alcohol Use Disorder and Tobacco Smoking, 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 5 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 7 Sep 2022. 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 7 Sep 2022). 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?
Laboratory Alcohol Consumption (time frame: Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pills.). 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 7 Sep 2022.