Daily Liraglutide for Nicotine Dependence

NCT03712098 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 831835
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking Cessation; Weight, Body

Outcome Measures

Primary Outcomes (2)

• Number of Participants With 7-day Point Prevalence Smoking Abstinence at 12 Weeks Post-Target Quit Date

  Biochemically verified carbon monoxide (CO) reading \<5 using a Vitalograph Breath CO Analyzer

  Week 18

• Number of Participants With 7-day Point Prevalence Smoking Abstinence at 26 Weeks Post-Target Quit Date

  Biochemically verified carbon monoxide (CO) reading \<5 using a Vitalograph Breath CO Analyzer

  Week 32

Secondary Outcomes (2)

• Body Weight at 12 Weeks Post-Target Quit Date

  Week 18

• Body Weight at 26 Weeks Post-Target Quit Date

  Week 32

Other Outcomes (1)

• Calories Consumed Per Day

  Weeks 0, 5, 18, & 32

Study Arms (2)

Smoking Cessation Counseling & Liraglutide

EXPERIMENTAL

Participants receive 8 sessions of smoking cessation behavioral counseling and 32 weeks of the medication liraglutide. Liraglutide comes in a pre-filled pen and is self-injected one time per day into the abdomen, thigh, or upper arm area. The dosing regimen, which follows FDA guidelines and is documented to be safe and well-tolerated in prior clinical studies, will begin at 0.6 mg and increase weekly by 0.6 mg until the recommended dose of 3 mg is reached (Weeks 1 through 5) and will continue at the 3 mg dose through the end of the study (Week 32).

Drug: Liraglutide; Behavioral: Smoking Cessation Counseling

Smoking Cessation Counseling & Placebo

ACTIVE COMPARATOR

Participants receive 8 sessions of smoking cessation behavioral counseling and 32 weeks of placebo. The placebo comes in a pre-filled pen and is self-injected one time per day into the abdomen, thigh, or upper arm area. The dosing regimen, which is the same as the liraglutide regimen, will begin at 0.6 mg and increase weekly by 0.6 mg until 3 mg is reached (Weeks 1 through 5) and will continue at the 3 mg dose through the end of the study (Week 32).

Drug: Placebo; Behavioral: Smoking Cessation Counseling

Interventions

Liraglutide DRUG

Liraglutide 3.0 mg is an injectable medicine that may help some adults with excess weight (BMI ≥27) who also have weight-related medical problems or obesity (BMI ≥30) lose weight and keep the weight off. Liraglutide is approved by the U.S. Food and Drug Administration (FDA) for chronic weight management when combined with a reduced-calorie meal plan and physical activity.

Also known as: Saxenda

Smoking Cessation Counseling & Liraglutide

Placebo DRUG

The placebo is an inactive substance that is designed to look like liraglutide but contains no medication.

Smoking Cessation Counseling & Placebo

Smoking Cessation Counseling BEHAVIORAL

All participants receive manual-based counseling from a trained smoking cessation counselor. The counseling sessions are designed to enhance awareness of the harmful effects of smoking, assist the participant in developing skills to quit, and avoid relapse.

Smoking Cessation Counseling & Liraglutide; Smoking Cessation Counseling & Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible subjects will be males and females:
• 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.
• Interested in quitting smoking (defined as "intend to quit within one month").
• 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.
• 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.
• Able to communicate (speak, read, and write) fluently in English.
• 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.
• If current or past diagnosis of bipolar disorder, eligible if:
• No psychotic features
• MADRS: total score less than 8 (past 4 weeks); suicidal item score less than 1 (past 4 weeks)
• Young Mania Rating Scale (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)
• No psychiatric hospitalization or Emergency Room visits for psychiatric issues in the past 6 months
• No aggressive or violent acts or behavior in the past 6 months

You may not qualify if:

• Subjects who present with and/or self-report the following criteria will not be eligible to participate in the study.
• Smoking Behavior:
• 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.
• Daily use of chewing tobacco, snuff and/or snus, or electronic cigarettes.
• Alcohol/Drug Use:
• Self-report current alcohol consumption that exceeds 25 standard drinks/week over the past 6 months.
• 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.
• A positive urine drug screen for cocaine, methamphetamines, phencyclidine (PCP), barbiturates, and/or ecstasy (MDMA).
• Participants believed to have a false-positive result on the drug screen may continue with the study with investigator approval.
• Medical:
• 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.
• Current diagnosis of unstable and untreated major depression, as determined by self-report \& MINI International Neuropsychiatric Interview (MINI) (eligible if stable for at least 30 days).
• 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.
• Suicide risk on the Columbia Suicide Severity Rating Scale (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.
• Self-reported kidney and/or liver disease or transplant.

Sponsors & Collaborators

• Rebecca Ashare: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Body Weight

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Rebecca Ashare
• Organization: SUNY Buffalo

rlashare@buffalo.edu

7168296273

Study Officials

• Rebecca L Ashare, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Department of Psychiatry

Model Details: This is a randomized, double-blind, placebo-controlled, parallel arm pilot study with one between-subjects factor of medication group (liraglutide vs. placebo).

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 19, 2018
• Study Start: November 29, 2018
• Primary Completion: May 25, 2022
• Study Completion: May 25, 2022
• Last Updated: September 21, 2023
• Results First Posted: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)