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

NCT ID: NCT03538808

Last Updated: 2020-12-14

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-06

Study Completion Date

2019-10-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Medication Adherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Balanced placebo design
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
double-blind

Study Groups

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Therapeutic Dose Truth

told therapeutic dose medication + received therapeutic dose medication

Group Type ACTIVE_COMPARATOR

Varenicline

Intervention Type DRUG

Participants will be provided varenicline medication

Therapeutic Dose Deception

told therapeutic dose medication + received placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Participants will be provided placebo medication

Low Dose Vareniclince Deception

told low dose medication + received therapeutic dose medication

Group Type ACTIVE_COMPARATOR

Varenicline

Intervention Type DRUG

Participants will be provided varenicline medication

Low Dose Placebo Deception

told low dose medication + received placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Participants will be provided placebo medication

Interventions

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Varenicline

Participants will be provided varenicline medication

Intervention Type DRUG

Placebo

Participants will be provided placebo medication

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Samantha Schiavon

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB-300001404

Identifier Type: -

Identifier Source: org_study_id