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

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• Dyssomnias 324
• Parasomnias 757

Dyssomnias

324 studies on the registry are indexed under Dyssomnias; 51 are open to participants now.

This study's enrollment of 26 is below the median of 60 across 251 interventional studies indexed under Dyssomnias.

Lead sponsor

Rose Research Center, LLC is the lead sponsor of 13 studies on the registry; none are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 3 (38%) have results posted.

Study arms

• Experimental
  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.

  Drug: Varenicline Pill · Drug: Hydroxyzine Pill

Interventions

• DrugVarenicline 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

  Also known as: Chantix

• DrugHydroxyzine 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.

Primary outcomes

1. 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.

   Time frame: Weeks 1, 2, 4, 8, 12

2. 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.

   Time frame: Weeks 1, 2, 4, 8, 12

3. 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

   Time frame: Weeks 1, 2, 4, 8, 12

Secondary outcomes

1. 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.

   Time frame: 7 Days

2. 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.

   Time frame: 7 Days

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · Jun 4, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No