Efficacy and Tolerability of Combination Varenicline With Hydroxyzine as a Potential Smoking Cessation Treatment

Completed · Phase 4

Conditions studied: Smoking Cessation, Stress, Sleep Disturbance, Nausea

In brief

This open-label study will evaluate hydroxyzine, a first-generation antihistamine, combined with varenicline, to help smokers abstain from smoking during a 12-week trial period by diminishing the nausea, stress, anxiety, and sleep disturbances associated with the use of varenicline and with nicotine withdrawal.

Key facts

Study ID

NCT04188106

Run by

Rose Research Center, LLC

People needed

26

Starts

2019-06-17

Expected to finish

2019-12-15

Last updated by the study team

2023-03-03

Who can join

Age: 19 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Has signed the consent form and is able to read and understand the information provided in the consent form.
• Is 19 to 65 years of age (inclusive) at screening.
• Smokes at least 10 commercially available cigarettes per day for the last 12 months.
• Has an expired air carbon monoxide reading of at least 10 ppm at screening.
• Express a desire to quit smoking within the next 30 days at screening.
• Willing and able to comply with the requirements of the study.
• Participant owns a smart phone with text message and data capabilities.

You may not qualify if…

• Is unhealthy or cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason) as judged by the Investigator or designated medical staff based on all available assessments from the screening period (e.g., safety laboratory, vital signs, physical examination, ECG, concomitant medications and medical history).
• PHQ-9 score greater than 9, or a score greater than 0 on item #9 ("Thoughts that you would be better off dead, or of hurting yourself in some way") at screening.
• High blood pressure (systolic > 150 mmHg or diastolic >95 mmHg) at screening.
• Body mass index (BMI) less than 15.0 kg/m2 or greater than 40.0 kg/m2.
• Coronary heart disease, structural cardiac disease, cardiac dysrhythmias, abnormal ECG (e.g. prolonged QTc), syncope, cardiac chest pain, or history of heart attack or heart failure.
• Has received psychotherapy or behavioral treatments potentially impacting symptoms of depression, anxiety, or nicotine withdrawal within 30 days of screening, or during the study.
• Taking antidepressants, psychoactive medications (e.g. antipsychotics, benzodiazepines, hypnotics) or medications that prolong QTc.
• Positive urine drug test for cocaine, marijuana, opiates, amphetamines or methamphetamines.
• Use of smokeless tobacco (chewing tobacco, snuff), cigars, pipes, hookah, e-cigarettes, nicotine replacement therapy or other smoking cessation treatments within 14 days of enrollment.
• Pregnant or nursing (by self-report) or has a positive pregnancy test.

Where it is running

• Rose Research Center — Charlotte, North Carolina, United States
• Rose Research Center — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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