Clinical trial NCT04188106: Efficacy and Tolerability of Combination Varenicline With Hydroxyzine as a Potential Smoking Cessation Treatment
Official title: Efficacy and Tolerability of Combination Varenicline With Hydroxyzine as a Potential Smoking Cessation Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Stress
Sleep Disturbance
Nausea
Lead sponsor: Rose Research Center, LLC
Sponsor class: INDUSTRY
Collaborators: name: Foundation for a Smoke Free World INC
First posted: 2019-12-05
Enrollment: 26
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label, single group study.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in 10-item Perceived Stress Scale (PSS-10) Following Smoking Cessation (While Taking Arenicline and Hydroxyzine).
timeFrame: Weeks 1, 2, 4, 8, 12
measure: Changes in Anxiety Using the 6-item State-Trait Anxiety Inventory (STAI)
timeFrame: Weeks 1, 2, 4, 8, 12
measure: Changes in Depression Using the Patient Health Questionnaire (PHQ-9)
timeFrame: Weeks 1, 2, 4, 8, 12
Secondary outcomes:
measure: Effects of Varenicline on Self-reported Smoking Reduction Prior to the Quit Date
timeFrame: 7 Days
measure: Effects of Varenicline on Self-reported Smoking Reduction Prior to the Quit Date
timeFrame: 7 Days
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Rose Research Center
state: North Carolina
city: Raleigh
country: United States
facility: Rose Research Center
state: North Carolina
Study officials:
References: