Daily Liraglutide for Nicotine Dependence

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This clinical research trial examines the effects of the GLP-1 receptor agonist liraglutide on smoking behavior, food intake, and weight gain. In this double-blind, placebo-controlled, parallel arm pilot study, overweight and obese smokers (N=40; 20 female and 20 male) will be randomized to 32 weeks of liraglutide or placebo and undergo 8 sessions of smoking cessation behavioral counseling. Outcomes are smoking abstinence and weight change.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rebecca Ashare
• Collaborator: Novo Nordisk A/S
• Treatments: Glucagon-Like Peptide 1; Liraglutide; Nicotine

Criteria

Inclusion Criteria:

Eligible subjects will be males and females:

1. 18 years of age or older who self-report smoking cigarettes (menthol and non-menthol) at least 10 times per day, on average, for the past 6 months.

2. Interested in quitting smoking (defined as "intend to quit within one month").

3. Body mass index (BMI) greater than or equal to 27 kg/m2 with one weight-related comorbidity (e.g. high blood pressure, high cholesterol, dyslipidemia) or greater than or equal to 30 kg/m2 per the manufacturer label for weight management.

4. Women of childbearing potential (based on medical history) must consent to use a medically accepted method of birth control (e.g., condoms and spermicide, oral contraceptive, Depo-Provera injection, contraceptive patch, intrauterine device (IUD), tubal ligation) or agree to abstain from sexual intercourse during the time they are in the study.

5. Able to communicate (speak, read, and write) fluently in English.

6. Capable of giving written informed consent before any study-related activities, which includes compliance with the requirements and restrictions listed in the combined consent/HIPAA form.

7. If current or past diagnosis of bipolar disorder, eligible if:

1. No psychotic features

2. MADRS: total score less than 8 (past 4 weeks); suicidal item score less than 1 (past 4 weeks)

3. Y-MRS: total score less than 8 (past 4 weeks); irritability, speech content, disruptive or aggressive behavior items score less than 3 (past 4 weeks)

4. No psychiatric hospitalization or Emergency Room visits for psychiatric issues in the past 6 months

5. No aggressive or violent acts or behavior in the past 6 months

Exclusion Criteria:

Subjects who present with and/or self-report the following criteria will not be eligible to participate in the study.

Smoking Behavior:

1. Current enrollment in a smoking cessation program, or use of other smoking cessation medications (e.g. Chantix/varenicline, Zyban/bupropion, nicotine replacement therapy/gum/patch, etc.) in the last month or plans to do either in the next 2 months.

2. Daily use of chewing tobacco, snuff and/or snus, or electronic cigarettes.

Alcohol/Drug Use:

1. Self-report current alcohol consumption that exceeds 25 standard drinks/week over the past 6 months.

2. Current untreated and unstable diagnosis of severe substance use disorder (eligible if past use and/or if receiving treatment and stable for at least 30 days). Current untreated and unstable moderate substance use disorder requires Study Physician approval.

3. A positive urine drug screen for cocaine, methamphetamines, PCP, barbiturates, and/or ecstasy (MDMA).

1. Participants believed to have a false-positive result on the drug screen may continue with the study with investigator approval.

Medical:

1. Females who self-report current pregnancy, planning a pregnancy during the study, currently breastfeeding/lactating, or not using adequate contraceptive measures. All female participants will undergo a urine pregnancy test at Intake and at every in-person study visit.

2. Current diagnosis of unstable and untreated major depression, as determined by self-report & MINI (eligible if stable for at least 30 days).

3. Current or past diagnosis of psychotic disorder, as determined by self-report or MINI. Mood Disorder with Psychotic Features determined by MINI requires PI approval for eligibility.

4. Suicide risk on the C-SSRS indicated by active suicidal ideation (within past 30 days), any suicidal attempt within the past 2 years, or 2 or more lifetime suicidal attempts.

5. Self-reported kidney and/or liver disease or transplant.

6. Heart/Cardiovascular disease (e.g., angina, coronary heart disease, stroke, etc.) in the past 6 months.

7. Type-1 or type-2 diabetes (previously diagnosed or indicated by HbA1c level of 6.5% or higher).

8. Uncontrolled hypertension (BP systolic greater than 159 and/or diastolic greater than 99)*.

9. Personal or family history of medullary thyroid carcinoma (MTC).

10. Personal or family history of Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

11. History of pancreatitis.

12. History of gallbladder disease.

13. A blood glucose level less than 70 mg/dl at the Intake Visit.

14. Prior history, or plans, of surgical intervention for weight loss.

15. Hypersensitivity to liraglutide or any product components.

16. Current diagnosis of hyperthyroidism or hypothyroidism (requires thyroid function test review by SP to determine eligibility)

17. Recent weight loss (more than or equal to 5% body weight) in the past 3 months

• Participants presenting with SBP greater than 159 mmHg and/or DBP greater than 99 mmHg at the Intake visit will be instructed to sit quietly for 10 minutes. Then the participant will have a second blood pressure reading taken after a 10 minute period. If, after the second reading the SBP greater than 159 mmHg and the DBP greater than 99 mmHg, the individual will be instructed to sit comfortably for 10 minutes and then have a third blood pressure reading. If, after the third reading the SBP greater than 159 mmHg and the DBP greater than 99 mmHg, the individual will be ineligible to participate.

Medications:

1. Current or recent use (last 14 days) of weight loss medication, and/or use of medications known to impact weight (e.g. corticosteroids, excluding inhaled).

General Exclusion:

1. Current, anticipated, or pending enrollment in another research program over the next 2-3 months that could potentially affect subject safety and/or the study data/design as determined by the Principal Investigator and/or Study Physician.

2. Not planning to live in the area for the next 9 months.

3. Previous participation in this trial (i.e., previously randomized and started study medication).

4. Any impairment (physical and/or neurological) including visual or other impairment preventing ability to complete study tasks.

5. Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator.