Combination Nicotine Patch / Lorcaserin for Smoking Cessation

NCT02906644 | Completed Phase 2 Results

• 2 other identifiers: Pro00074741P50DA027840-06
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

This study plans to compare the efficacy of the nicotine patch / lorcaserin combination treatment vs. the nicotine patch alone in terms of leading to a reduction in smoking behavior and withdrawal symptoms.

Conditions

Nicotine Dependence

Keywords

Nicotine addiction; Cigarette smoking; Smoking cessation; lorcaserin; Belviq; Nicotine patches

Outcome Measures

Primary Outcomes (2)

• Time-to-lapse

  Two weeks after treatment is initiated, with nicotine patch + lorcaserin or nicotine patch alone, but still two weeks prior to the quit day, subjects will be evaluated in a modified version of the McKee Smoking Lapse Task. In this task smokers, who have been abstinent for 2 hours will be provided with the option to smoke at any time, but paid by the minute for remaining abstinent with progressively decreasing payments over an hour.

  Week 2 pre quit day

• Smoking Withdrawal

  At the study visit above (two week post treatment initiation but 2 weeks prior to quit day), withdrawal symptoms will be assessed after 2 hours of smoking abstinence using the Shiffman-Jarvik (short form) questionnaire, which consists of 9 items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 9 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, and Arousal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.

  Week 2 pre quit day

Secondary Outcomes (6)

• Number of Participants Reporting Smoking Abstinence

  Weeks 7-10 post quit day

• Number of Participants Reporting Tolerability Issues With Lorcaserin + Nicotine Patch Treatment

  Two Weeks pre and 10 weeks post quit day

• Weight Gain Following Continuous Four-week Abstinence From Smoking

  Week 10 post quit day

• Number of Participants Reporting 6-month Smoking Abstinence

  6 months post Quit Day

• Percentage of Change in Ad Libitum Smoking at End of Week 2

  Week 2 pre quit day

Study Arms (2)

Lorcaserin + Patch

EXPERIMENTAL

Participants will receive lorcaserin (10mg twice a day) and nicotine patches (21mg/24hr) for 14 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week.

Drug: lorcaserin; Drug: nicotine patch

Patch

EXPERIMENTAL

Participants will receive nicotine patches (21mg/24hr) and placebo lorcaserin for 2 weeks; after 2 weeks participants will begin to receive active lorcaserin (10mg twice a day) along with the nicotine patches for 12 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week.

Drug: lorcaserin; Drug: nicotine patch; Drug: placebo lorcaserin

Interventions

lorcaserin DRUG

Also known as: Belviq

Lorcaserin + Patch; Patch

nicotine patch DRUG

Also known as: Nicoderm

Lorcaserin + Patch; Patch

placebo lorcaserin DRUG

Also known as: placebo Belviq

Patch

Eligibility Criteria

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

You may qualify if:

• years old;
• Smoke an average of at least 10 cigarettes per day;
• Have smoked at least one cumulative year;
• Have an expired air CO reading of at least 10ppm;
• Body weight of \>50 kg (110 lbs.)
• Able to read and understand English;
• Express a desire to quit smoking in the next thirty days.

You may not qualify if:

• Hypertension (systolic \>140 mm Hg, diastolic \>100 mm Hg, coupled with a history of hypertension); subjects with no previous diagnosis of hypertension may have a screening blood pressure up to 160/100.
• Hypotension with symptoms (systolic \<90 mm Hg, diastolic \<60 mm Hg).
• Participants with a history of hypertension may, however, be allowed to participate in the study if the study physician or physician assistant determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual's safety.
• Coronary heart disease, diagnosed by coronary angiogram;
• Lifetime history of heart attack;
• Cardiac rhythm disorder (irregular heart rhythm);
• Chest pain in the last month (unless history, exam, and ECG clearly indicate a non-cardiac source);
• Symptomatic cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
• Diagnosis of liver disease or kidney disorder (except kidney stones, gallstones);
• Gastrointestinal problems (e.g. Celiac disease, Crohn's dx Ulcerative Colitis) or disease other than gastroesophageal reflux or heartburn;
• Active ulcers in the past 30 days;
• Currently symptomatic lung disorder/disease (including but not limited to chronic obstructive pulmonary disease (COPD), emphysema, and asthma);
• Brain abnormality (including but not limited to stroke, brain tumor, and seizure disorder);
• Migraine headaches that occur more frequently than once per week;
• Recent, unexplained fainting spells;

Sponsors & Collaborators

• Duke University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Duke Center for Smoking Cessation

Durham, North Carolina, 27705, United States

Location

Related Publications (2)

• Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.

  PMID: 34611902 DERIVED

• Rose JE, Davis JM. Combination Lorcaserin and Nicotine Patch for Smoking Cessation Without Weight Gain. Nicotine Tob Res. 2020 Aug 24;22(9):1627-1631. doi: 10.1093/ntr/ntz149.

  PMID: 31589323 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Cigarette Smoking; Smoking Cessation

Interventions

lorcaserin; Tobacco Use Cessation Devices; Nicotine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Tobacco Smoking; Smoking; Behavior; Tobacco Use; Health Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Clinical Research Coordinator
• Organization: Duke University

al.salley@duke.edu

(919) 668-5055

Study Officials

• Jed E. Rose, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2016
• First Posted: September 20, 2016
• Study Start: November 8, 2016
• Primary Completion: March 27, 2018
• Study Completion: October 18, 2018
• Last Updated: May 7, 2019
• Results First Posted: May 7, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)