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

The University of Alabama at Birmingham

Status and phase: Completed; Phase 4

Conditions: Medication Adherence

Treatments: Other: Placebo; Drug: Varenicline

Study type: Interventional

Funder types: Other

Identifiers

NCT03538808

IRB-300001404

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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80 participants in 4 patient groups, including a placebo group

Therapeutic Dose Truth

Active Comparator group

Description:

told therapeutic dose medication + received therapeutic dose medication

Treatment:

Drug: Varenicline

Therapeutic Dose Deception

Placebo Comparator group

Description:

told therapeutic dose medication + received placebo

Treatment:

Other: Placebo

Low Dose Vareniclince Deception

Active Comparator group

Description:

told low dose medication + received therapeutic dose medication

Treatment:

Drug: Varenicline

Low Dose Placebo Deception

Placebo Comparator group

Description:

told low dose medication + received placebo

Treatment:

Other: Placebo