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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Daily Liraglutide for Nicotine Dependence

Short name DAL

Overview

Status
Completed
Phase
Phase 2
Enrollment
40 participants (actual)
Sponsor
Rebecca Ashare · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
29 Nov 2018
Primary completion
25 May 2022
Completion
25 May 2022
First posted
19 Oct 2018
Last update posted
21 Sept 2023
Conditions
Smoking Cessation · Weight, Body

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201820192020202120222023
  1. Ph 2

    DAL

    NCT03712098

    29 Nov 2018 to 25 May 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LiraglutideDrug
  • PlaceboDrug
  • Smoking Cessation CounselingBehavioral

Arms2

  • 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 outcomes2

Outcomes the sponsor listed as primary.

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

    Time frame · Week 18

    Registry description

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

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

    Time frame · Week 32

    Registry description

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

Secondary outcomes(2)
  1. Body Weight at 12 Weeks Post-Target Quit Date

    Time frame · Week 18

    Registry description

    Body weight will be measured by digital scale (pounds, ounces) wearing light clothing without shoes

  2. Body Weight at 26 Weeks Post-Target Quit Date

    Time frame · Week 32

    Registry description

    Body weight will be measured by digital scale (pounds, ounces) wearing light clothing without shoes

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Week 18

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

GroupValue (Participants)
Smoking Cessation Counseling & Liraglutide2
Smoking Cessation Counseling & Placebo2
Primary outcomeCount of participants· Week 32

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

GroupValue (Participants)
Smoking Cessation Counseling & Liraglutide2
Smoking Cessation Counseling & Placebo2
Secondary and other outcome results(3)
Secondary outcomeMean· Week 18

Body Weight at 12 Weeks Post-Target Quit Date

GroupValue (lb)Spread
Smoking Cessation Counseling & Liraglutide209.814.4
Smoking Cessation Counseling & Placebo212.617.8
Secondary outcomeMean· Week 32

Body Weight at 26 Weeks Post-Target Quit Date

GroupValue (lb)Spread
Smoking Cessation Counseling & Liraglutide234.437.6
Smoking Cessation Counseling & Placebo209.819.0
Other pre specified outcomeMean· Weeks 0, 5, 18, & 32

Calories Consumed Per Day

GroupValue (kcal/day)Spread
Smoking Cessation Counseling & Liraglutide1994.4680.7
Smoking Cessation Counseling & Placebo1703.9484.7

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Smoking Cessation Counseling & LiraglutideParticipants 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). Liraglutide: 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. Smoking Cessation Counseling: 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.0 / 190 / 1918 / 19
Smoking Cessation Counseling & PlaceboParticipants 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). Placebo: The placebo is an inactive substance that is designed to look like liraglutide but contains no medication. Smoking Cessation Counseling: 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.0 / 212 / 2120 / 21

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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. 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) 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, phencyclidine (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 International Neuropsychiatric Interview (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 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. 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 study physician (SP) to determine eligibility) 17. Recent weight loss (more than or equal to 5% body weight) in the past 3 months * Participants presenting with systolic blood pressure (SBP) greater than 159 mmHg and/or diastolic blood pressure (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.

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