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Balanced Placebo Design With Varenicline: Pharmacological and Expectancy Effects on Medication Adherence

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ClinicalTrials.gov Identifier: NCT03538808
Recruitment Status : Recruiting
First Posted : May 28, 2018
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Samantha Schiavon, University of Alabama at Birmingham

Brief Summary:
The current study will use the double-blind balanced placebo design to examine differences between expectancies versus the pharmacological effects of varenicline medication administered for two weeks to cigarette smokers. The double-blind balanced placebo design includes medication administration (active medication v. placebo) and medication information (told truth v. deception) resulting in four groups of smokers: (1) told therapeutic dose (TD) medication + received TD medication; (2) told TD medication + received placebo; (3) told low dose (LD) medication+ received TD dose medication; (4) told LD medication + received placebo. Ecological momentary assessments (EMA) in the form of Daily Dairies delivered via smartphone will assess real-time side effects, withdrawal symptoms, cigarettes smoked, medication use, and reasons for medication non-adherence.

Condition or disease Intervention/treatment Phase
Medication Adherence Drug: Varenicline Other: Placebo Phase 4

Detailed Description:

The current proposal will utilize the double-blind balanced placebo design to differentiate expectancies versus pharmacologic mechanisms of varenicline administered to varenicline naïve smokers seeking treatment (N = 80) for two-weeks. Race block randomization (controlling for baseline expectancies) will be used to randomize participants. The double-blind balanced placebo design includes a cross-balanced medication administration (active medication v. placebo) and instructional set (told truth v. deception) resulting in four groups of smokers seeking treatment (n = 20 for each): (1) told therapeutic dose (TD) medication + received TD medication; (2) told TD medication + received placebo; (3) told low dose (LD) medication+ received TD dose medication; (4) told LD medication + received placebo. Participants will be told they received low dose (rather than placebo) due to concerns that participants will not take a medication that they believe to be a placebo. Ecological momentary assessments (EMA) in the form of Daily Dairies delivered via smartphone will assess real-time side effects, withdrawal symptoms, cigarettes smoked, medication use, and reasons for medication non-adherence. The current proposal will test the following specific aims:

Specific Aim 1: Examine the main effects of instructional set and pharmacology. Hypothesis 1: Main effects for TD instructional set and active medication administration will result in reduced medication adherence compared with LD instructional set and placebo medication.

Specific Aim 2: Examine the interaction between instructional set and pharmacology. Hypothesis 2: There will be a synergistic (i.e., non-additive) effect between instructional set and pharmacology. Specifically, those assigned to the TD instructional set and active medication group will result in a 50% discontinuation compared to a 20% discontinuation in the TD instructional set and placebo medication group.

Exploratory Aim: Evaluate moderators of pharmacology and expectancy effects on medication adherence. First, we will conduct exploratory examination of baseline medication expectancies moderating the relationship between pharmacology and medication adherence. Second, we will conduct an exploratory evaluation of potential moderators (e.g., gender and race) of pharmacology and baseline medication expectancy.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Balanced placebo design
Masking: Double (Participant, Investigator)
Masking Description: double-blind
Primary Purpose: Treatment
Official Title: Varenicline Pharmacological and Expectancy Effects on Medication Adherence (Balanced Placebo Design With Varenicline: Pharmacological and Expectancy Effects on Medication Adherence)
Actual Study Start Date : November 6, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Therapeutic Dose Truth
told therapeutic dose medication + received therapeutic dose medication
Drug: Varenicline
Participants will be provided varenicline medication

Placebo Comparator: Therapeutic Dose Deception
told therapeutic dose medication + received placebo
Other: Placebo
Participants will be provided placebo medication

Active Comparator: Low Dose Vareniclince Deception
told low dose medication + received therapeutic dose medication
Drug: Varenicline
Participants will be provided varenicline medication

Placebo Comparator: Low Dose Placebo Deception
told low dose medication + received placebo
Other: Placebo
Participants will be provided placebo medication




Primary Outcome Measures :
  1. Medication Adherence [ Time Frame: Days 1 - 13 ]
    Self-reported medication adherence measured through a single item each morning referring to yesterday's medication compliance. The item is answered as "yes" or "no" and options regarding reasons for non-adherence. Reasons for non-adherence include: forgot, side effects, medication not working, I don't need the medication anymore.


Secondary Outcome Measures :
  1. Medication Expectancies [ Time Frame: Baseline and Day 13 ]
    Medication expectancies will be measured through 3 self-reported questionnaires (SETS, BAV, and BMQ) at the baseline and final visit. The Stanford Expectations of Treatment Scale (SETS) is a 6-item questionnaire to assess expectancies about the efficacy of treatment (rated on a scale from 1 strongly disagree to 7 strongly agree). The Beliefs and Attitudes about Varenicline (BAV) is a 6-item questionnaire adapted to assess varenicline expectancies (rated on a scale from 1 = not at all to 5 = extremely). The Beliefs about Medicines Questionnaire (BMQ) is an 18-item scale the focuses on general beliefs regarding medicines and specific beliefs regarding their prescribed medicines (rated on a scale from 1 = strongly disagree to 5 = strongly agree).


Other Outcome Measures:
  1. Side Effects [ Time Frame: Days 1 - 13 ]
    Measured through a 30-item self-report questionnaire measuring the presence or not (rate as 0 = No and 1 = Yes) of side effects commonly associated with pharmacotherapy and quitting smoking.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years or older
  • Smoking at least 5 cigarettes per day (cpd) for the past year
  • A carbon monoxide (CO) >10ppm
  • English speaking
  • Must own a cellphone with SMS text capacity with Internet access OR daily use of email
  • Must be varenicline naïve
  • Express a desire to quit smoking

Exclusion Criteria:

  • Living in a restricted environment (e.g., prison or jail facility, etc.)
  • Pregnant or nursing
  • Currently enrolled in a smoking cessation treatment program, using NRT products, or prescribed bupropion or varenicline
  • Known allergy to varenicline
  • History of kidney disease, dialysis or known kidney impairment
  • Cognitive impairment or unstable psychiatric condition that interferes with the informed consent process (individuals stable on psychiatric medications will be included)
  • Daily or exclusive use of other tobacco products
  • Current suicidal or homicidal ideation or a suicidal attempt within the past 12 months
  • History of stroke, heart attack, or seizures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538808


Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Samantha P Schiavon, M.A.    205-975-4528    sschiavon@uabmc.edu   
Contact: Karen L Cropsey, PsyD    (205)975-4204    kcropsey@uab.edu   
Sponsors and Collaborators
University of Alabama at Birmingham

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Responsible Party: Samantha Schiavon, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03538808     History of Changes
Other Study ID Numbers: IRB-300001404
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs