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Medication removed from the U.S. market by the The Food and Drug Administration
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorcaserin Oral Tablet | Drug | Lorcasering 10mg Oral Tablet (BID) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Laboratory Alcohol Consumption | Number of drinks consumed during a 2-hour alcohol self-administration session | Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pills. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pills |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Hendershot, Ph.D. | The Mind Research Network | Principal Investigator |
| Eric Claus, Ph.D. | The Mind Research Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Mind Research Network | Albuquerque | New Mexico | 87106 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lorcaserin First, Then Placebo | 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. |
| FG001 | Placebo First, Then Lorcaserin | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
5 participants provided informed consent. Due to participant no-shows and the cancelation of the study, only one participant started study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lorcaserin First, Then Placebo | Lorcaserin (10mg BID), then placebo pill (BID) |
| BG001 | Placebo First, Then Lorcaserin | Placebo pill (BID), then Lorcaserin (10mg BID) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Laboratory Alcohol Consumption | Number of drinks consumed during a 2-hour alcohol self-administration session | The trial was halted after randomizing the first two participants. Only one participant completed the dependent measures. | Posted | Number | drinks | Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pills. |
|
2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lorcaserin | Lorcaserin (10mg BID) Lorcaserin Oral Tablet: Lorcasering 10mg Oral Tablet (BID) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christian Hendershot | UNC-Chapel Hill | (919) 962-5565 | christian_hendershot@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 10, 2019 | Apr 5, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 10, 2019 | Apr 5, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D000073869 | Tobacco Smoking |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C506658 | lorcaserin |
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| Placebo oral tablet | Drug | Placebo Oral Tablet (BID) |
|
|
| 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. | 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. | 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 | During 7 days of medication or during 7 days of placebo pills. |
| Cigarette Consumption | Number of cigarettes smoked per day | During 7 days of medication or during 7 days of placebo pills. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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. | The trial was halted after randomizing the first two participants. Only one participant completed the dependent measures. | Posted | Number | score on a scale | Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pills |
|
|
|
| Secondary | 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. | The trial was halted after randomizing the first two participants. Only one participant completed the dependent measures. | Posted | Number | elasticity | Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pills. |
|
|
|
| Secondary | 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. | The trial was halted after randomizing the first two participants. Only one participant completed the dependent measures. | Posted | Number | elasticity | Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pills. |
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| Secondary | Daily Alcohol Consumption | Self-reported drinks per drinking day | The trial was halted after randomizing the first two participants. Only one participant completed the dependent measures. | Posted | Number | Drinks per drinking day | During 7 days of medication or during 7 days of placebo pills. |
|
|
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| Secondary | Cigarette Consumption | Number of cigarettes smoked per day | The trial was halted after randomizing the first two participants. Only one participant completed the dependent measures. | Posted | Number | cigarettes per day | During 7 days of medication or during 7 days of placebo pills. |
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|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Placebo | Placebo pill (BID) Placebo oral tablet: Placebo Oral Tablet (BID) | 0 | 1 | 0 | 1 | 0 | 1 |
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| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |