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

NCT03538808 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB-300001404
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Medication Adherence

Outcome Measures

Primary Outcomes (1)

• Medication Adherence

  Self-reported medication adherence measured through a single item assessing medication compliance. The item is answered as "yes" (scored as 1) or "no" (scored as 0). This measure combines all responses from Day 1 through Day 13 of this study to provide a total measure of medication adherence ranging from 0% (missed all doses) to 100% (took every dose as prescribed). Higher scores indicate better outcomes (i.e., better adherence to medication).

  Days 1 - 13

Secondary Outcomes (1)

• Medication Expectancies

  Baseline and Day 14

Other Outcomes (1)

• Side Effects

  Day 14

Study Arms (4)

Therapeutic Dose Truth

ACTIVE COMPARATOR

told therapeutic dose medication + received therapeutic dose medication

Drug: Varenicline

Therapeutic Dose Deception

PLACEBO COMPARATOR

told therapeutic dose medication + received placebo

Other: Placebo

Low Dose Vareniclince Deception

ACTIVE COMPARATOR

told low dose medication + received therapeutic dose medication

Drug: Varenicline

Low Dose Placebo Deception

PLACEBO COMPARATOR

told low dose medication + received placebo

Other: Placebo

Interventions

Varenicline DRUG

Participants will be provided varenicline medication

Low Dose Vareniclince Deception; Therapeutic Dose Truth

Placebo OTHER

Participants will be provided placebo medication

Low Dose Placebo Deception; Therapeutic Dose Deception

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Medication Adherence

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Limitations and Caveats

(1) Reliance on self-report data, particularly for medication adherence, may have produced biased results with participants reporting higher adherence as an artifact of social desirability. (2) Although the primary outcome was to observe instances of nonadherence within the early initiation of varenicline, limiting the medication regimen to two weeks may have hindered observations in this study. (3) No information was collected related to the degree of severity for each reported side effect.

Results Point of Contact

• Title: Samantha Schiavon
• Organization: University of Alabama at Birmingham

sschiavon@uabmc.edu

9515509388

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Balanced placebo design

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 29, 2018
• Study Start: November 6, 2018
• Primary Completion: October 29, 2019
• Study Completion: October 29, 2019
• Last Updated: December 14, 2020
• Results First Posted: December 14, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)