Status:
TERMINATED
Laboratory Screening of Lorcaserin for Alcohol Use Disorder
Lead Sponsor:
The Mind Research Network
Conditions:
Alcohol Use Disorder
Tobacco Smoking
Eligibility:
All Genders
21-65 years
Phase:
PHASE2
Brief 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. Although heav...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- 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
Key Trial Info
Start Date :
October 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2020
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04396847
Start Date
October 25 2019
End Date
February 26 2020
Last Update
September 7 2022
Active Locations (1)
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1
The Mind Research Network
Albuquerque, New Mexico, United States, 87106