Phase 2
Completed N=61
Combination Nicotine Patch / Lorcaserin for Smoking Cessation
Nicotine Dependence
Source: ClinicalTrials.gov NCT02906644 ↗
Enrolled (actual)
61
Serious AEs
1.2%
Results posted
May 2019
Primary outcomePrimary: Time-to-lapse — 51.97; 56.44 Minutes
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-to-lapse |
51.97; 56.44 | — |
| PRIMARY Smoking Withdrawal |
2.81; 2.91; 2.15; 2.21; 4.73; 4.72 | — |
| SECONDARY Number of Participants Reporting Smoking Abstinence |
9; 10 | — |
| SECONDARY Number of Participants Reporting Tolerability Issues With Lorcaserin + Nicotine Patch Treatment |
26 | — |
| SECONDARY Weight Gain Following Continuous Four-week Abstinence From Smoking |
-0.35 | — |
| SECONDARY Number of Participants Reporting 6-month Smoking Abstinence |
9 | — |
| SECONDARY Percentage of Change in Ad Libitum Smoking at End of Week 2 |
-35.58; -47.13 | — |
| SECONDARY Adherence to Lorcaserin + Nicotine Patch Treatment as Indicator of Tolerability |
72.15 | — |
Eligibility Criteria
Inclusion Criteria
- 18-65 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.
Exclusion Criteria
- 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 9 (or who score >0 on item #9 ("Thoughts that you would be better off dead, or of hurting yourself in some way") will be excluded from study participation, and, at the discretion of the study physician, referred to appropriate psychiatric treatment;
- Bulimia or anorexia;
- BMI of < 18.5 kg/m2;
- Prior use of fenfluramine or dexfenfluramine
- Use (within the past 30 days) of:
- Illegal drugs (or if the urine drug screen is positive for tetrahydrocannabinol (THC), Cocaine, Amphetamine, Opiates, Methamphetamines, phencyclidine (PCP), Benzodiazepines, or Barbiturates), Unless recent use of prescription Opiates, Benzodiazepines for management of acute symptoms.
- Experimental (investigational) drugs;
- Psychiatric medications including antidepressants (selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs), St. John's Wort), lithium, anti-psychotics or any other medications that are known to affect smoking cessation (e.g. clonidine);
- Phentermine, triptans, tryptophan, linezolid, dextromethorphan, opiates, tramadol, or dopamine agonists;
- Any agents that have documented correlation with increased incidence of valvulopathy and/or pulmonary hypertension (e.g., cyproheptadine, trazodone, nefazodone, amoxapine, tricyclic antidepressants, mirtazapine, pergolide, ergotamine, methysergide) (or anticipated use during the study);
- Smokeless tobacco (chewing tobacco, snuff), pipes or e-cigarettes;
- Wellbutrin, bupropion, Zyban, Chantix, varenicline, nicotine patch, nicotine replacement therapy or any other smoking cessation aid.
- Concurrent use of a serotonergic agent/combination associated with severe serotonin syndrome (within the past 30 days);
- Use of cigar, cigarillos, pipe, Hookah, dissolvable nicotine, snuff, chewing tobacco more than once per month.
- Use of e-cigarettes once per month or more.
- Self-report of consuming 4 or more alcoholic drinks on 1 or more days per week;
- Significant adverse reaction to lorcaserin or nicotine patch in the past.
- Current participation or recent participation (in the past 30 days) in another smoking study at the investigators Center or another research facility.
- Current participation in another research study.
Data sourced from ClinicalTrials.gov (NCT02906644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.