Medication AdherencePhase 4NCT03538808
Balanced Placebo Design With Varenicline: Pharmacological and Expectancy Effects on Medication Adherence
A Phase 4 study testing Varenicline in people with Medication Adherence, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Adherence
- What is being tested?
- Varenicline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2018to 29 Oct 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Varenicline Pharmacological and Expectancy Effects on Medication Adherence (Balanced Placebo Design With Varenicline: Pharmacological and Expectancy Effects on Medication Adherence)
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.
Read the 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.
- Conditions
- Medication Adherence
- Being tested
- Varenicline, Placebo
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Participants will be provided varenicline medication
PlaceboOther
Participants will be provided placebo medication
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Dose Truth | Active comparator | told therapeutic dose medication + received therapeutic dose medication Receives: Drug: Varenicline |
| Therapeutic Dose Deception | Placebo comparator | told therapeutic dose medication + received placebo Receives: Other: Placebo |
| Low Dose Vareniclince Deception | Active comparator | told low dose medication + received therapeutic dose medication Receives: Drug: Varenicline |
| Low Dose Placebo Deception | Placebo comparator | told low dose medication + received placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Days 1 - 13
Secondary outcomes (1)
Medication Expectancies
Medication expectancies will be measured through the Beliefs and Attitudes about Varenicline (BAV) scale which is a 6-item questionnaire adapted to assess varenicline expectancies. This measure is rated on a scale from 1 (not at all) to 5 (extremely). The measure has a minimum score of 6 and a maximum score of 30. Higher scores indicating better outcomes (i.e., stronger positive beliefs about using varenicline).
Measured: Baseline and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start6 Nov 2018
- Primary completion29 Oct 2019
- Study completion29 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Balanced placebo design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samantha Schiavon, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538808
- Sponsor's protocol ID
- IRB-300001404
- Status last verified
- Nov 2020
- First submitted
- 15 May 2018
- Last updated
- 14 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Varenicline Pharmacological and Expectancy Effects on Medication Adherence (Balanced Placebo Design With Varenicline: Pharmacological and Expectancy Effects on Medication Adherence)
- ClinicalTrials.gov ID
- NCT03538808
- Acronym / sponsor ID
- IRB-300001404
- Conditions
- Medication Adherence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 29 Oct 2019 (actual)
- Study completion
- 29 Oct 2019 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Posted 14 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Balanced placebo design
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Dose Truth | Active comparator | Drug: Vareniclinetold therapeutic dose medication + received therapeutic dose medication |
| Therapeutic Dose Deception | Placebo comparator | Other: Placebotold therapeutic dose medication + received placebo |
| Low Dose Vareniclince Deception | Active comparator | Drug: Vareniclinetold low dose medication + received therapeutic dose medication |
| Low Dose Placebo Deception | Placebo comparator | Other: Placebotold low dose medication + received placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VareniclineParticipants will be provided varenicline medication | Drug | Low Dose Vareniclince Deception, Therapeutic Dose Truth |
| PlaceboParticipants will be provided placebo medication | Other | Low Dose Placebo Deception, Therapeutic Dose Deception |
Primary outcome
Medication Adherence
Time frame: Days 1 - 13
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).
1 secondary outcome
Medication Expectancies
Time frame: Baseline and Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Varenicline in people with Medication Adherence, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence (time frame: Days 1 - 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.