Daily Liraglutide for Nicotine Dependence

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Rebecca Ashare
Study ID
NCT03712098
Phase
PHASE2
Status
Completed

Conditions

  • Smoking Cessation
  • Weight, Body

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Nov 29, 2018
Status verified
Sep 2023
Primary completion
May 25, 2022
Completion
May 25, 2022

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Smoking Cessation Counseling & Liraglutide
    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).
  • Active Comparator: Smoking Cessation Counseling & Placebo
    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).

Primary Outcome Measure

Number of Participants With 7-day Point Prevalence Smoking Abstinence at 12 Weeks Post-Target Quit Date [ Time Frame: Week 18 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Center for Interdisciplinary Research on Nicotine Addiction, University of PennsylvaniaPhiladelphiaPennsylvania19104-

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By research site
Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania· Philadelphia, PA

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