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

Rose Research Center

Status and phase: Completed; Phase 4

Conditions: Nausea; Sleep Disturbance; Smoking Cessation; Stress

Treatments: Drug: Hydroxyzine Pill; Drug: Varenicline Pill

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04188106

HAVE

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. 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).
2. 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.
3. High blood pressure (systolic > 150 mmHg or diastolic >95 mmHg) at screening.
4. Body mass index (BMI) less than 15.0 kg/m2 or greater than 40.0 kg/m2.
5. 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.
6. Has received psychotherapy or behavioral treatments potentially impacting symptoms of depression, anxiety, or nicotine withdrawal within 30 days of screening, or during the study.
7. Taking antidepressants, psychoactive medications (e.g. antipsychotics, benzodiazepines, hypnotics) or medications that prolong QTc.
8. Positive urine drug test for cocaine, marijuana, opiates, amphetamines or methamphetamines.
9. 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.
10. Pregnant or nursing (by self-report) or has a positive pregnancy test.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Hydroxyzine and Varenicline

Experimental group

Description:

Participants enrolled in the study will take the FDA approved starter kit of varenicline for the first week of medication administration (0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7). During the first week, participants will also receive hydroxyzine dosed in a similar manner, 50 mg nightly for the first 3 days, then twice daily, 25 mg in the morning and 50 mg at night. After the first week, participants will receive the FDA-approved dose of varenicline (1 mg twice daily) combined with hydroxyzine, 25 mg in the morning and 50 mg at nighttime. All medications will be dosed orally.

Treatment:

Drug: Hydroxyzine Pill

Drug: Varenicline Pill