Primary outcome
What DAL measured first
| Smoking Cessation Counseling & Liraglutiden=19 | Smoking Cessation Counseling & Placebon=21 |
|---|---|
| 2 | 2 |
| Smoking Cessation Counseling & Liraglutiden=19 | Smoking Cessation Counseling & Placebon=21 |
|---|---|
| 2 | 2 |
Phase 2 · Liraglutide
DAL trial results
Glucagon-like Peptide-1 Receptor Agonists as Novel Pharmacotherapies for Nicotine Dependence
Number of Participants With 7-day Point Prevalence Smoking Abstinence at 12 Weeks Post-Target Quit Date (Participants), Week 18. Smoking Cessation Counseling & Liraglutide: 2; Smoking Cessation Counseling & Placebo: 2.
- Participants
- 40
- Status
- completed
- Completed
- 2022-05-25
- Sponsor
- Rebecca Ashare
As posted on ClinicalTrials.gov (NCT03712098), updated at source Sep 21, 2023. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in DAL
Percent of participants affected, 8 months. The most common events the registry lists.
| Event | Smoking Cessation Counseling & Liraglutide | Smoking Cessation Counseling & Placebo |
|---|---|---|
| Any serious event | 0% | 9.5% |
| Decreased Appetite | 78.9% | 61.9% |
| Nausea | 63.2% | 38.1% |
| Fatigue | 57.9% | 42.9% |
| Headache | 47.4% | 57.1% |
| Hypertension | 36.8% | 57.1% |
| Constipation | 52.6% | 19% |
| Dry Mouth | 26.3% | 47.6% |
| Insomnia | 36.8% | 47.6% |
| Anxiety | 21.1% | 38.1% |
| Diarrhea | 31.6% | 14.3% |
| Dizziness | 31.6% | 28.6% |
| Vomiting | 31.6% | 9.5% |
| Acid Reflux | 26.3% | 19% |
| Flatulence | 26.3% | 23.8% |
| Indigestion | 26.3% | 9.5% |
| Abdominal Pain | 21.1% | 19% |
| Belching | 21.1% | 9.5% |
| Bruising at injection site | 21.1% | 19% |
| Bloating | 5.3% | 19% |
Secondary outcomes
What else it measured
| Smoking Cessation Counseling & Liraglutiden=3 | Smoking Cessation Counseling & Placebon=8 |
|---|---|
| 209.8(14.4) | 212.6(17.8) |
| Smoking Cessation Counseling & Liraglutiden=2 | Smoking Cessation Counseling & Placebon=7 |
|---|---|
| 234.4(37.6) | 209.8(19.0) |
The trial
How DAL was run
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.
- 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...
- 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).
Who could join the trial
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...
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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