Smoking CessationPhase 4NCT04089982
Varenicline Light Smoking Pilot
A Phase 4 study testing Varenicline in people with Smoking Cessation and Smoking Behaviors, run by Duke University at 1 site in United States.
Trial summary
The goal of this study is to assess varenicline vs. placebo for its effect on decreasing cue reactivity in light and intermittent smokers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Smoking Behaviors, Smoking
- What is being tested?
- Varenicline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2019to 1 Mar 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or above
- Daily smoker using 10 or less cigarettes per day but a minimum of at least 1 cigarettes per week or 4 cigs/month.
- Must be able to make it through a 24-hour period without nicotine withdrawal symptoms (specifically does not have new onset of irritability, headaches, insomnia, or intense cravings).
- Willing to quit smoking in the next 30 days
- Is able to provide written informed consent (in English) to participate in the study and is able to read/understand the procedures and study requirements.
- Is willing to voluntarily sign and date an informed consent form that is approved by an institutional review board before the conduct of any study procedure.
- If female and of childbearing potential, is willing to use medically acceptable contraceptive measures for the duration of the study. Acceptable methods of contraception include (1) surgical sterilization (such as tubal ligation or hysterectomy, (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD). Contraceptive measures such as rhythm method or Plan B™, sold for emergency use after unprotected sex, are not acceptable methods for routine use.
- Have access to a cell phone that can send and receive SMS text messages.
Who cannot join
- Use of a smoking cessation medication (e.g. nicotine replacement, varenicline, bupropion) in last 30 days.
- Current use of tobacco product other than cigarettes (e.g. e-cigarettes, smokeless tobacco) in the last 30 days
- Answer > 0 on suicidality question of Patient Health Questionnaire (PHQ-9) Depression Scale
- Active alcohol use disorder or hazardous drinking. This will be screened with the AUDIT-C, and positive scores (4 or greater for men and 3 or greater for women)54,55 will result in study clinician assessment and discretion.
- Use of illicit drugs in the last month (marijuana, cocaine, opiates, benzodiazepines, and/or methamphetamine)
- Severe symptomatic depression and or anxiety (study medical provider discretion)
Show all 14Show fewer
- Diagnosis of bipolar disorder, schizophrenia, PTSD and or adult ADHD (study medical provider discretion)
- Chronic medical illness including diabetes with the use of insulin, Hemoglobin A1c > 7 (study medical provider discretion), heart disease diagnosed by angiogram, or COPD diagnosed by pulmonary function testing and requiring an oxygen supply
- Specific medications (Appendix 1)
- Abnormal finding on physical exam (study medical provider discretion)
- Positive Urine Pregnancy Test (women of child bearing potential only; QuickVue Urine Pregnancy)56
- Positive Urine Toxicology-5 Screen (methamphetamine, cocaine, opiates, benzodiazepines, THC)
- Unstable hypertension (Blood pressure > 160/100)
- Renal failure with active or pending hemodialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study on Varenicline in Light and Intermittent Smokers
The goal of this study is to assess varenicline vs. placebo for its effect on decreasing cue reactivity in light and intermittent smokers.
Read the detailed description
The study will consist of randomization to receive either varenicline or placebo over 6 weeks and include 5 study visits. Participants are offered an optional additional 6 weeks of active varenicline. Cue reactivity will be assessed in both a lab-based setting (viewing series of images and rating cravings) and in a real-world setting (text-based daily interaction).
- Conditions
- Smoking Cessation, Smoking Behaviors, Smoking
- Being tested
- Varenicline, Placebo oral tablet
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Chantix
Placebo oral tabletDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Varenicline | Active comparator | Varenicline BID Receives: Drug: Varenicline |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-Reported Craving Level Via Lab-Based Cue Reactivity
Participants were asked to self-report craving level to smoke on a scale of 1-10 with 1 corresponding to no craving and 10 corresponding to intense craving. Self-reported craving level was requested following presentation of multiple images on a screen over a 20 minute period. Four types of images were presented - neutral affect, negative affect, smoking and social images.
Measured: Baseline, Visit 4 (week 6)
Secondary outcomes (5)
Change in Self-Reported Craving Level Via Real-World Cue Reactivity
Craving level in "real world" situations was assessed through electronic momentary assessment (EMA). Participants were instructed to send a text to the study team each time they experienced craving to smoke a cigarette. Self-report craving level to smoke was reported on a scale of 1-10 with 1 corresponding to no craving and 10 corresponding to intense craving.
Measured: Baseline, Visit 4 (week 6)
Changes in Smoking
7-day point prevalence smoking abstinence. This will be measured through self-reported daily smoking diaries and daily text messaging.
Measured: Screening visit, Visit 4 (week 6)
Medication Adherence
Medication adherence is measured by composite self-reported diaries and daily text messaging responses.
Measured: Screening visit, Visit 4 (week 6)
Medication Tolerance by Self-Reported Side Effects
Self-reported side effects (open ended survey questions) with a ranking scale of 1-2 (mild), 3-5 (moderate), and 6-7 (severe). Any side effect 3 or greater will be reviewed by a study medical provider.
Measured: Up to 12 weeks
Changes in Smoking Abstinence
7-day point prevalence smoking abstinence confirmed by CO <7ppm. This will be measured through biochemical confirmation (CO breath test).
Measured: Screening visit, Visit 4 (week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start4 Nov 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
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 Smoking CessationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Parallel groups
- Model description
- 2-arm randomized, placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Davis, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089982
- Sponsor's protocol ID
- Pro00103506
- Status last verified
- May 2021
- First submitted
- 12 Sep 2019
- Last updated
- 11 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Varenicline in Light and Intermittent Smokers
- ClinicalTrials.gov ID
- NCT04089982
- Acronym / sponsor ID
- Pro00103506
- Conditions
- Smoking Cessation, Smoking Behaviors, Smoking
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 16 Sep 2019 (actual)
- Results
- Posted 11 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to assess varenicline vs. placebo for its effect on decreasing cue reactivity in light and intermittent smokers.
Detailed description
The study will consist of randomization to receive either varenicline or placebo over 6 weeks and include 5 study visits. Participants are offered an optional additional 6 weeks of active varenicline. Cue reactivity will be assessed in both a lab-based setting (viewing series of images and rating cravings) and in a real-world setting (text-based daily interaction).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2-arm randomized, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Varenicline | Active comparator | Drug: VareniclineVarenicline BID |
| Placebo | Placebo comparator | Drug: Placebo oral tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years or above
- Daily smoker using 10 or less cigarettes per day but a minimum of at least 1 cigarettes per week or 4 cigs/month.
- Must be able to make it through a 24-hour period without nicotine withdrawal symptoms (specifically does not have new onset of irritability, headaches, insomnia, or intense cravings).
- Willing to quit smoking in the next 30 days
- Is able to provide written informed consent (in English) to participate in the study and is able to read/understand the procedures and study requirements.
Key exclusion criteria (14 listed)
- Use of a smoking cessation medication (e.g. nicotine replacement, varenicline, bupropion) in last 30 days.
- Current use of tobacco product other than cigarettes (e.g. e-cigarettes, smokeless tobacco) in the last 30 days
- Answer > 0 on suicidality question of Patient Health Questionnaire (PHQ-9) Depression Scale
- Active alcohol use disorder or hazardous drinking. This will be screened with the AUDIT-C, and positive scores (4 or greater for men and 3 or greater for women)54,55 will result in study clinician assessment and discretion.
- Use of illicit drugs in the last month (marijuana, cocaine, opiates, benzodiazepines, and/or methamphetamine)
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 |
|---|---|---|
| VareniclineChantix | Drug | Varenicline |
| Placebo oral tabletPlacebo | Drug | Placebo |
Primary outcome
Change in Self-Reported Craving Level Via Lab-Based Cue Reactivity
Time frame: Baseline, Visit 4 (week 6)
Participants were asked to self-report craving level to smoke on a scale of 1-10 with 1 corresponding to no craving and 10 corresponding to intense craving. Self-reported craving level was requested following presentation of multiple images on a screen over a 20 minute period. Four types of images were presented - neutral affect, negative affect, smoking and social images.
5 secondary outcomes
Change in Self-Reported Craving Level Via Real-World Cue Reactivity
Time frame: Baseline, Visit 4 (week 6)
Changes in Smoking
Time frame: Screening visit, Visit 4 (week 6)
Medication Adherence
Time frame: Screening visit, Visit 4 (week 6)
Medication Tolerance by Self-Reported Side Effects
Time frame: Up to 12 weeks
Changes in Smoking Abstinence
Time frame: Screening visit, Visit 4 (week 6)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No individual participant data will be shared.
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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.
James Davis, MD principal investigator
Duke University
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 Smoking Cessation and Smoking Behaviors, run by Duke University 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 8 inclusion and 14 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 11 May 2021. 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 11 May 2021). 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?
Change in Self-Reported Craving Level Via Lab-Based Cue Reactivity (time frame: Baseline, Visit 4 (week 6)). 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 11 May 2021.