Smoking CessationPhase 2DALNCT03712098
Daily Liraglutide for Nicotine Dependence
A Phase 2 study testing Liraglutide and Smoking Cessation Counseling in people with Smoking Cessation and Weight, Body, run by Rebecca Ashare at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Weight, Body
- What is being tested?
- Liraglutide and Smoking Cessation Counseling
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2018to 25 May 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible subjects will be males and females:
- 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.
- 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.
Show all 13Show fewer
- 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
Who cannot join
- 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.
Show all 36Show fewer
- 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.
- Heart/Cardiovascular disease (e.g., angina, coronary heart disease, stroke, etc.) in the past 6 months.
- Type-1 or type-2 diabetes (previously diagnosed or indicated by HbA1c level of 6.5% or higher).
- Uncontrolled hypertension (BP systolic greater than 159 and/or diastolic greater than 99)*.
- Personal or family history of medullary thyroid carcinoma (MTC).
- Personal or family history of Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- History of pancreatitis.
- History of gallbladder disease.
- A blood glucose level less than 70 mg/dl at the Intake Visit.
- Prior history, or plans, of surgical intervention for weight loss.
- Hypersensitivity to liraglutide or any product components.
- Current diagnosis of hyperthyroidism or hypothyroidism (requires thyroid function test review by study physician (SP) to determine eligibility)
- 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:
- 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.
- Not planning to live in the area for the next 9 months.
- Previous participation in this trial (i.e., previously randomized and started study medication).
- Any impairment (physical and/or neurological) including visual or other impairment preventing ability to complete study tasks.
- Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Glucagon-like Peptide-1 Receptor Agonists as Novel Pharmacotherapies for Nicotine Dependence
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.
Read the detailed description
Tobacco use and obesity are the two leading causes of preventable deaths. A growing literature indicates that common neurobiological substrates mediate drug addiction and obesity. Therefore, it is not surprising that during smoking abstinence, highly palatable food may serve as a substitute reinforcer ultimately leading to increased body weight gain. Importantly, post-cessation weight gain (PCWG) can deter a quit attempt, precipitate smoking relapse, and contribute to health issues related to excess body weight. The majority of weight gain occurs within 3-6 months of quitting smoking and many individuals maintain this increased weight 5 to 20 years post-cessation. Although there is substantial variability in the amount of weight gained, individuals who successfully quit smoking gain an average of 4.2 kg, with estimates ranging from 2.5 kg to 8.6 kg, at 6-month follow-up. Weight gain after smoking cessation contributes to increased risk of obesity, type II diabetes mellitus and hypertension (18), as well as reducing the improvement in lung function conferred by smoking cessation. Moreover, overweight or obese smokers comprise 70% of treatment-seeking smokers, gain the most weight, and are the least accepting of PCWG. Thus, post-cessation weight gain is a significant clinical problem. Unfortunately, current pharmacological interventions to reduce post-cessation weight gain are not very effective.
While weight gain is often cited as a primary reason for smoking relapse, there is a significant gap in our understanding of the biobehavioral mechanisms linking smoking cessation and overeating. Recent evidence indicates that glucagon-like peptide-1 (GLP-1) regulates the rewarding effects of nicotine. These effects are mediated, in part, by reduced dopamine signaling in the nucleus accumbens, a key brain region known to regulate the reinforcing effects of both drugs of abuse and palatable foods. Indeed, activation of GLP-1 receptors in the ventral tegmental area (VTA), a brain region that sends dopaminergic projections to the nucleus accumbens, reduces both drug intake and consumption of palatable food. Based on the ability of GLP-1 receptor agonists to reduce drug and food intake, it is plausible that targeting GLP-1 receptor signaling may be an effective strategy toward reducing withdrawal-induced weight gain in abstinent smokers.
Investigators have recently developed a novel animal model of nicotine withdrawal-induced hyperphagia and body weight gain in order to gain an improved understanding of the molecular and behavioral mechanisms underlying increased food intake and body weight gain during nicotine withdrawal. The pilot data provide strong empirical rationale for the proposed study by establishing an animal model of withdrawal-induced hyperphagia and body weight gain following voluntary nicotine self-administration. This withdrawal phenotype was evident only in rats given ad libitum access to a highly palatable diet during withdrawal as parallel studies using a normal chow diet did not produce hyperphagia or changes in body weight during nicotine withdrawal (data not shown). Collectively,these results are consistent with human laboratory studies indicating that nicotine withdrawal is associated with increased consumption of highly palatable foods and body weight. The translational implications of studying this behavioral phenotype are clear and significant and include: 1) informing clinical approaches to treating weight gain during smoking abstinence, 2) identifying potential biomarkers associated with nicotine addiction, and 3) addressing two significant public health concerns.
GLP-1 receptor ligands are currently FDA-approved for the treatment of type II diabetes mellitus and obesity. Re-purposing an existing FDA-approved treatment that has been "de-risked" (i.e., previously shown to be safe) in numerous clinical trials removes a key barrier for drug development and reduces the resources required to bring new drugs to market.
The promising preclinical data, combined with evidence that GLP-1 receptor agonists are effective treatments for obesity, suggest that GLP-1 receptor ligands could be re-purposed for attenuating nicotine withdrawal-induced bodyweight gain, thereby improving smoking cessation rates. Specifically, this study will examine the effects of the GLP-1 receptor agonist liraglutide on smoking behavior as well as food intake and body weight gain during abstinence.
- Conditions
- Smoking Cessation, Weight, Body
- Being tested
- Liraglutide, Placebo, Smoking Cessation Counseling
- Medical subject headings
- Smoking Cessation, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Also called Saxenda
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.
PlaceboDrug
The placebo is an inactive substance that is designed to look like liraglutide but contains no medication.
Smoking Cessation CounselingBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Placebo; Behavioral: Smoking Cessation Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Week 32
Secondary outcomes (2)
Body Weight at 12 Weeks Post-Target Quit Date
Body weight will be measured by digital scale (pounds, ounces) wearing light clothing without shoes
Measured: Week 18
Body Weight at 26 Weeks Post-Target Quit Date
Body weight will be measured by digital scale (pounds, ounces) wearing light clothing without shoes
Measured: Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start29 Nov 2018
- Primary completion25 May 2022
- Study completion25 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double-blind, placebo-controlled, parallel arm pilot study with one between-subjects factor of medication group (liraglutide vs. placebo).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rebecca Ashare
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor-investigator, Rebecca Ashare, University of Pennsylvania
- Investigators
- Rebecca L Ashare, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712098
- Sponsor's protocol ID
- 831835
- Acronym
- DAL
- Status last verified
- Sep 2023
- First submitted
- 11 Oct 2018
- Last updated
- 21 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucagon-like Peptide-1 Receptor Agonists as Novel Pharmacotherapies for Nicotine Dependence
- ClinicalTrials.gov ID
- NCT03712098
- Acronym / sponsor ID
- DAL / 831835
- Conditions
- Smoking Cessation, Weight, Body
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rebecca AshareUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Posted 21 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Tobacco use and obesity are the two leading causes of preventable deaths. A growing literature indicates that common neurobiological substrates mediate drug addiction and obesity. Therefore, it is not surprising that during smoking abstinence, highly palatable food may serve as a substitute reinforcer ultimately leading to increased body weight gain. Importantly, post-cessation weight gain (PCWG) can deter a quit attempt, precipitate smoking relapse, and contribute to health issues related to excess body weight. The majority of weight gain occurs within 3-6 months of quitting smoking and many individuals maintain this increased weight 5 to 20 years post-cessation. Although there is substantial variability in the amount of weight gained, individuals who successfully quit smoking gain an average of 4.2 kg, with estimates ranging from 2.5 kg to 8.6 kg, at 6-month follow-up. Weight gain after smoking cessation contributes to increased risk of obesity, type II diabetes mellitus and hypertension (18), as well as reducing the improvement in lung function conferred by smoking cessation. Moreover, overweight or obese smokers comprise 70% of treatment-seeking smokers, gain the most weight, and are the least accepting of PCWG. Thus, post-cessation weight gain is a significant clinical problem. Unfortunately, current pharmacological interventions to reduce post-cessation weight gain are not very effective.
While weight gain is often cited as a primary reason for smoking relapse, there is a significant gap in our understanding of the biobehavioral mechanisms linking smoking cessation and overeating. Recent evidence indicates that glucagon-like peptide-1 (GLP-1) regulates the rewarding effects of nicotine. These effects are mediated, in part, by reduced dopamine signaling in the nucleus accumbens, a key brain region known to regulate the reinforcing effects of both drugs of abuse and palatable foods. Indeed, activation of GLP-1 receptors in the ventral tegmental area (VTA), a brain region that sends dopaminergic projections to the nucleus accumbens, reduces both drug intake and consumption of palatable food. Based on the ability of GLP-1 receptor agonists to reduce drug and food intake, it is plausible that targeting GLP-1 receptor signaling may be an effective strategy toward reducing withdrawal-induced weight gain in abstinent smokers.
Investigators have recently developed a novel animal model of nicotine withdrawal-induced hyperphagia and body weight gain in order to gain an improved understanding of the molecular and behavioral mechanisms underlying increased food intake and body weight gain during nicotine withdrawal. The pilot data provide strong empirical rationale for the proposed study by establishing an animal model of withdrawal-induced hyperphagia and body weight gain following voluntary nicotine self-administration. This withdrawal phenotype was evident only in rats given ad libitum access to a highly palatable diet during withdrawal as parallel studies using a normal chow diet did not produce hyperphagia or changes in body weight during nicotine withdrawal (data not shown). Collectively,these results are consistent with human laboratory studies indicating that nicotine withdrawal is associated with increased consumption of highly palatable foods and body weight. The translational implications of studying this behavioral phenotype are clear and significant and include: 1) informing clinical approaches to treating weight gain during smoking abstinence, 2) identifying potential biomarkers associated with nicotine addiction, and 3) addressing two significant public health concerns.
GLP-1 receptor ligands are currently FDA-approved for the treatment of type II diabetes mellitus and obesity. Re-purposing an existing FDA-approved treatment that has been "de-risked" (i.e., previously shown to be safe) in numerous clinical trials removes a key barrier for drug development and reduces the resources required to bring new drugs to market.
The promising preclinical data, combined with evidence that GLP-1 receptor agonists are effective treatments for obesity, suggest that GLP-1 receptor ligands could be re-purposed for attenuating nicotine withdrawal-induced bodyweight gain, thereby improving smoking cessation rates. Specifically, this study will examine the effects of the GLP-1 receptor agonist liraglutide on smoking behavior as well as food intake and body weight gain during abstinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind, placebo-controlled, parallel arm pilot study with one between-subjects factor of medication group (liraglutide vs. placebo).
| Arm | Type | Receives |
|---|---|---|
| Smoking Cessation Counseling & Liraglutide | Experimental | Drug: Liraglutide, Behavioral: Smoking Cessation CounselingParticipants 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). |
| Smoking Cessation Counseling & Placebo | Active comparator | Drug: Placebo, Behavioral: Smoking Cessation CounselingParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
- 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.
Key exclusion criteria (36 listed)
- Subjects who present with and/or self-report the following criteria will not be eligible to participate in the study.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiraglutideAlso: SaxendaLiraglutide 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. | Drug | Smoking Cessation Counseling & Liraglutide |
| PlaceboThe placebo is an inactive substance that is designed to look like liraglutide but contains no medication. | Drug | Smoking Cessation Counseling & Placebo |
| Smoking Cessation CounselingAll 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. | Behavioural | Smoking Cessation Counseling & Liraglutide, Smoking Cessation Counseling & Placebo |
Primary outcome
Number of Participants With 7-day Point Prevalence Smoking Abstinence at 12 Weeks Post-Target Quit Date
Time frame: Week 18
Biochemically verified carbon monoxide (CO) reading <5 using a Vitalograph Breath CO Analyzer
Number of Participants With 7-day Point Prevalence Smoking Abstinence at 26 Weeks Post-Target Quit Date
Time frame: Week 32
Biochemically verified carbon monoxide (CO) reading <5 using a Vitalograph Breath CO Analyzer
2 secondary outcomes
Body Weight at 12 Weeks Post-Target Quit Date
Time frame: Week 18
Body Weight at 26 Weeks Post-Target Quit Date
Time frame: Week 32
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Smoking Cessation
Recruiting
Smoking Cessation in Patients With Cancer
Cancer, Tobacco Use
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruiting
Effectiveness Of Project EX: A Classroom-Based Smoking Prevention And Cessation Intervention Program
Focus of the Study is Smoking Cessation and Prevention, Smoking Prevention
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
Recruiting
Therapeutic Contact Intensity in a Psychological Smoking Cessation Intervention With an App
Smoking Behaviors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca L Ashare, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liraglutide and Smoking Cessation Counseling in people with Smoking Cessation and Weight, Body, run by Rebecca Ashare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With 7-day Point Prevalence Smoking Abstinence at 12 Weeks Post-Target Quit Date (time frame: Week 18). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.