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

Stress Clinical Trial

— HAVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04188106
• Other study ID #: HAVE
• Status: Completed
• Phase: Phase 4
• Start date: June 17, 2019
• Est. completion date: December 15, 2019

Study information

• Verified date: February 2023
• Source: Rose Research Center, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 15, 2019
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyssomnias
• Nausea
• Parasomnias
• Sleep Disturbance
• Smoking Cessation
• Stress

Intervention

Drug:
• 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
• 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.

Locations

Country	Name	City	State
United States	Rose Research Center	Charlotte	North Carolina
United States	Rose Research Center	Raleigh	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Rose Research Center, LLC	Foundation for a Smoke-Free World

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 10-item Perceived Stress Scale (PSS-10) Following Smoking Cessation (While Taking Arenicline and Hydroxyzine).	Stress levels in the last 30 days will be measured using the 10-item Perceived Stress Scale (PSS-10). The PSS-10 uses a 5-point scale (0 - never, 1 = almost never, 2 = once in a while, 3 = often, 4 = very often). Total scores range from 0 to 40.; Scores ranging from 0-13 would be considered low stress.; Scores ranging from 14-26 would be considered moderate stress.; Scores ranging from 27-40 would be considered high perceived stress.	Weeks 1, 2, 4, 8, 12
Primary	Changes in Anxiety Using the 6-item State-Trait Anxiety Inventory (STAI)	Trait and state anxiety levels will be monitored for changes using the 6-item State-Trait Anxiety Inventory (STAI). All items are rated on a 4-point scale ("1-Almost Never" to "4-Almost Always"). The range of scores is from 6 to 24. Higher scores indicate greater anxiety.	Weeks 1, 2, 4, 8, 12
Primary	Changes in Depression Using the Patient Health Questionnaire (PHQ-9)	Depression will be monitored for changes using the Patient Health Questionnaire (PHQ-9). The PHQ-9 uses a 4-point scale (Not at all = 0; Several days = 1;More than half the days = 2; Nearly every day = 3). The sum of the scores is calculated (Score range is 0 to 27): 1-4 Minimal depression; 5-9 Mild depression; 10-14 Moderate depression; 15-19 Moderately severe depression; 20-27 Severe depression	Weeks 1, 2, 4, 8, 12
Secondary	Effects of Varenicline on Self-reported Smoking Reduction Prior to the Quit Date	Previous research has shown that abstinence at the end of treatment is strongly predicted by the extent to which smokers spontaneously reduce ad libitum smoking in the initial weeks of pharmacotherapy that is initiated before the quit-smoking date.; This measure will assess the extent of smoking reduction in participants during the initial seven days of treatment (prior to their planned quit date) - assessed via a self-report number of cigarettes per day. Data is recorded as a mean change.	7 Days
Secondary	Effects of Varenicline on Self-reported Smoking Reduction Prior to the Quit Date	Previous research has shown that abstinence at the end of treatment is strongly predicted by the extent to which smokers spontaneously reduce ad libitum smoking in the initial weeks of pharmacotherapy that is initiated before the quit-smoking date.; This measure will assess the extent of smoking reduction in participants during the initial seven days of treatment (prior to their planned quit date) - assessed via expired air carbon monoxide (CO). Data is recorded as a mean change.	7 Days