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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-17

Study Completion Date

2019-12-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Smoking Cessation Stress Sleep Disturbance Nausea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open-label, single group study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hydroxyzine and Varenicline

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.

Group Type EXPERIMENTAL

Varenicline Pill

Intervention Type DRUG

FDA approved starter kit of varenicline (0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7) followed by FDA-approved dose of varenicline (1 mg twice daily) for the remaining 11 weeks

Hydroxyzine Pill

Intervention Type DRUG

For the first week, participants will receive 50 mg nightly for the first 3 days, then twice daily, 25 mg in the morning and 50 mg at night for the remaining 12 weeks.

Interventions

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Varenicline Pill

FDA approved starter kit of varenicline (0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7) followed by FDA-approved dose of varenicline (1 mg twice daily) for the remaining 11 weeks

Intervention Type DRUG

Hydroxyzine Pill

For the first week, participants will receive 50 mg nightly for the first 3 days, then twice daily, 25 mg in the morning and 50 mg at night for the remaining 12 weeks.

Intervention Type DRUG

Other Intervention Names

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Chantix

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes