Combination Nicotine Patch / Lorcaserin for Smoking Cessation

Completed · Phase 2 · Has a placebo group

Conditions studied: Nicotine Dependence

In brief

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.

Key facts

Study ID

NCT02906644

Run by

Duke University

People needed

97

Starts

2016-11-08

Expected to finish

2018-10-18

Last updated by the study team

2019-05-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

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;
• Problems giving blood samples;
• Diabetes (unless controlled by diet and exercise alone and screening glucose is less than 180mg/dcl and HbA1c is less than 7%);
• Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer);
• HIV, Hepatitis B, or Hepatitis C
• History of tuberculosis or recent positive purified protein derivative (PPD) test
• Other major medical condition;
• Current psychiatric disease (with the exception of anxiety disorders, obsessive compulsive disorder (OCD) and ADHD);
• Suicidal ideating (thinking about ways to commit suicide) (within the past 10 years) or lifetime occurrence of attempted suicide;
• Current depression - The Patient Health Questionnaire (PHQ-9) for Depression will be used to screen for current (within 2 weeks) depression. Potential subjects who score >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;

Where it is running

• Duke Center for Smoking Cessation — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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