Alcohol Use Disorder Clinical Trial
Official title:
Human Laboratory Screening of Lorcaserin in Smokers With Alcohol Use Disorder
Verified date | August 2022 |
Source | The Mind Research Network |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 5 |
Est. completion date | February 26, 2020 |
Est. primary completion date | February 26, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Age 21-65 2. 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 3. Daily smoker, defined as reporting smoking 1+ cigarettes per day, on average, over the past 12 months 4. Willingness to take study pills and complete study procedures 5. Willingness to complete lab sessions involving alcohol administration Exclusion Criteria: 1. Recent (30 day) illicit drug use (with the exception of cannabis) based on self-report or toxicology screen 2. Meeting DSM-5 criteria for a past-year substance use disorder other than alcohol use disorder, tobacco use disorder, or mild cannabis use disorder 3. 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) 4. Past 30-day use of nicotine replacement 5. Past 30-day use of SSRIs, other psychiatric medications, or weight control medications 6. Lifetime diagnosis of severe mental illness (e.g., psychotic or bipolar I disorder) 7. 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 8. Current alcohol or smoking cessation treatment or efforts to cut down on drinking/smoking 9. Medications contraindicated for use with lorcaserin or which have a significant interaction with lorcaserin 10. Body mass index (BMI) under normal range (<18kg/m2) 11. History of significant cardiovascular conditions including history of arrhythmias or heart block, heart failure, valvular heart disease, heat attack, stroke, unstable angina 12. Abnormal electrocardiogram (ECG) results 13. Currently nursing, pregnant, or anticipating pregnancy 14. history of suicide attempt or recent suicidal ideation (i.e., Suicidal thoughts (intent or plan) in the last month) 15. Plans to travel outside of the local area during the study period, or inability to commit to entire duration of study |
Country | Name | City | State |
---|---|---|---|
United States | The Mind Research Network | Albuquerque | New Mexico |
Lead Sponsor | Collaborator |
---|---|
The Mind Research Network |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
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. | 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. | 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. | Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pills. | |
Secondary | Daily Alcohol Consumption | Self-reported drinks per drinking day | During 7 days of medication or during 7 days of placebo pills. | |
Secondary | Cigarette Consumption | Number of cigarettes smoked per day | During 7 days of medication or during 7 days of placebo pills. |
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