Tobacco Use CessationPhase 3NCT03416621
Project Q Pilot: Smoking Cessation for Light Smokers
A Phase 3 study testing Cognitive behavioral cessation counseling and Counseling and active drug intervention in people with Tobacco Use Cessation, run by Duke University at 1 site in United States.
Trial summary
The purpose of this pilot study is to evaluate the feasibility, acceptability, and preliminary efficacy of an intervention to promote smoking cessation among light smokers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- Cognitive behavioral cessation counseling and Counseling and active drug intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2018to 29 Feb 2020
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: ≥18 years old
- Able to read and understand English or Spanish
- Cognitively able to provide informed consent
- Smoke 1-10 cigs/day on at least 4 days in the past month
- Express a desire to quit smoking in the next 30 days
- Access to a cell phone that can send and receive SMS text messages and take and send pictures
Who cannot join
- Hypertension with a screening blood pressure over 160/100;
- Hypotension with a screening blood pressure of systolic <90 mm Hg, diastolic <60 mm Hg;
- Participants with a history of hypertension may be allowed to participate in the study if the study physician or physician assistant determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual's safety;
- Coronary heart disease, diagnosed by coronary angiogram;
- History of major heart attack;
- Major cardiac rhythm disorder determined by study MD;
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- Chest pain in the last month (unless history, exam, indicate a non-cardiac source);
- Symptomatic cardiac disorder (valvular heart disease, heart murmur, heart failure);
- Diagnosis of severe liver disease or kidney disorder;
- Major gastrointestinal problems or disease (Celiac, Crohn's, Ulcerative Colitis)
- Bleeding ulcers in the past 30 days;
- Current, advanced lung disorder/disease (COPD, emphysema);
- Migraine headaches that occur more frequently than once per week;
- Recent, unexplained fainting spells;
- Problems giving blood samples;
- Diabetes not controlled by diet and exercise alone;
- Current cancer or cancer treatment in the past six months (except basal or squamous cell skin cancer);
- HIV, Hepatitis B, or Hepatitis C;
- History of Tuberculosis or recent positive PPD;
- Other major medical condition;
- Current symptomatic, uncontrolled psychiatric disease;
- Diagnosis of serious mental illness, including bipolar disorder and schizophrenia;
- Suicidal ideation within the past month or lifetime occurrence of attempted suicide;
- Current (within 2 weeks) depression determined by PHQ-9 score > 9 or > 0 on item #9
- Bulimia or anorexia;
- Pregnant or nursing;
- Use (within the past 30 days) of:
- Illegal drugs (or if the urine drug screen is positive for Cocaine, Amphetamine, Opiates, Methamphetamines, PCP, Benzodiazepines, or Barbiturates), unless prescribed for management of acute symptoms (tooth extraction, recent surgery);
- Experimental (investigational) drugs;
- Psychiatric medications including antidepressants (MAOIs, St. John's Wort), lithium, anti-psychotics, or any other medications that are known to affect smoking cessation (e.g. clonidine);
- Wellbutrin, bupropion, Zyban, Chantix, varenicline, nicotine patch, nicotine replacement therapy or any other smoking cessation aid.
- Use of cigars, cigarillos, pipes, Hookah, dissolvable nicotine, snuff, chewing tobacco , or e-cigarettes within the past 30 days;
- Positive result on AUDIT-C;
- Self-report of marijuana use ≥ 4 days per week;
- Significant adverse reaction to D-cycloserine in the past;
- Current or recent (in the past 30 days) participation in another smoking study at our Center or another research facility
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center - Cancer Prevention, Detection and Control
Durham, North Carolina, 27710
About this study
Official title: Project Q Pilot: Examining Different Treatment Modalities to Maximize Cessation Efforts for Light Smokers
The purpose of this pilot study is to evaluate the feasibility, acceptability, and preliminary efficacy of an intervention to promote smoking cessation among light smokers.
Read the detailed description
The three-arm randomized controlled trial compares Arm 1) standard smoking cessation plus support text messages, 2) enhanced cue exposure treatment (lab-based + interactive SMS texting) + D-cycloserine placebo, Arm 3)will include a combination of cognitive behavioral cessation counseling, enhanced cue exposure treatment (lab-based + interactive SMS texting) and a cognitive-enhancing drug - D-cycloserine. In addition to an in-person screening visit, we will conduct three in-person treatment visits and an inperson follow-up visit.
- Conditions
- Tobacco Use Cessation
- Being tested
- Cognitive behavioral cessation counseling, Counseling and placebo drug intervention, Counseling and active drug intervention
- Keywords
- Light Smoker
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral cessation counselingBehavioural
Standard smoking cessation plus support text messages
Counseling and placebo drug interventionBehavioural
Enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo
Counseling and active drug interventionDrug
Enhanced cue exposure treatment (lab-based + interactive SMS texting)+ active DCS. In addition to an in-person, screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Cognitive behavioral cessation counseling | Active comparator | Standard smoking cessation plus support text messages Receives: Behavioral: Cognitive behavioral cessation counseling |
| Placebo Comparator: Counseling and placebo drug intervention | Placebo comparator | enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo Receives: Behavioral: Cognitive behavioral cessation counseling; Behavioral: Counseling and placebo drug intervention |
| Active Comparator: Counseling and active drug intervention | Experimental | enhanced cue exposure treatment (lab-based + interactive SMS texting) + active DCS. In addition to an in-person screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit. Receives: Behavioral: Cognitive behavioral cessation counseling; Drug: Counseling and active drug intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Completion of at Least 2 Study Visits
Feasibility will be determined by number of participants that complete at least 2 study visits.
Measured: Approximately 8 weeks
Number of Participants Who Rated the Intervention Acceptable
Acceptability will be determined by the number of patients rating the intervention usefulness in the experimental and control arms on a 7-point Likert scale, where 1=extremely useless and 7=extremely useful.
Measured: Approximately 8 weeks
Secondary outcomes (1)
Number of Participants With Validated Cessation
Biochemically-validated cessation (absence of salivary cotinine) 1 week post-intervention.
Measured: 1 week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start17 May 2018
- Primary completion29 Feb 2020
- Study completion29 Feb 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathryn Pollak, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416621
- Sponsor's protocol ID
- Pro00089760
- Status last verified
- Mar 2021
- First submitted
- 24 Jan 2018
- Last updated
- 29 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pollak KI, Oliver JA, Pieper C, Davis JM, Gao X, Noonan D, Kennedy D, Granados I, Fish LJ. Cue-based treatment for light smokers: A proof of concept pilot. Addict Behav. 2021 Mar;114:106717. doi: 10.1016/j.addbeh.2020.106717. Epub 2020 Oct 17.
PubMed 33109394
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Q Pilot: Examining Different Treatment Modalities to Maximize Cessation Efforts for Light Smokers
- ClinicalTrials.gov ID
- NCT03416621
- Acronym / sponsor ID
- Pro00089760
- Conditions
- Tobacco Use Cessation
- Keywords
- Light Smoker
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 17 May 2018 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 31 Jan 2018 (actual)
- Results
- Posted 24 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to evaluate the feasibility, acceptability, and preliminary efficacy of an intervention to promote smoking cessation among light smokers.
Detailed description
The three-arm randomized controlled trial compares Arm 1) standard smoking cessation plus support text messages, 2) enhanced cue exposure treatment (lab-based + interactive SMS texting) + D-cycloserine placebo, Arm 3)will include a combination of cognitive behavioral cessation counseling, enhanced cue exposure treatment (lab-based + interactive SMS texting) and a cognitive-enhancing drug - D-cycloserine. In addition to an in-person screening visit, we will conduct three in-person treatment visits and an inperson follow-up visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: Cognitive behavioral cessation counseling | Active comparator | Behavioral: Cognitive behavioral cessation counselingStandard smoking cessation plus support text messages |
| Placebo Comparator: Counseling and placebo drug intervention | Placebo comparator | Behavioral: Cognitive behavioral cessation counseling, Behavioral: Counseling and placebo drug interventionenhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo |
| Active Comparator: Counseling and active drug intervention | Experimental | Behavioral: Cognitive behavioral cessation counseling, Drug: Counseling and active drug interventionenhanced cue exposure treatment (lab-based + interactive SMS texting) + active DCS. In addition to an in-person screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: ≥18 years old
- Able to read and understand English or Spanish
- Cognitively able to provide informed consent
- Smoke 1-10 cigs/day on at least 4 days in the past month
- Express a desire to quit smoking in the next 30 days
Key exclusion criteria (36 listed)
- Hypertension with a screening blood pressure over 160/100;
- Hypotension with a screening blood pressure of systolic <90 mm Hg, diastolic <60 mm Hg;
- Participants with a history of hypertension may be allowed to participate in the study if the study physician or physician assistant determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual's safety;
- Coronary heart disease, diagnosed by coronary angiogram;
- History of major heart attack;
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 |
|---|---|---|
| Cognitive behavioral cessation counselingStandard smoking cessation plus support text messages | Behavioural | Active Comparator: Counseling and active drug intervention, Experimental: Cognitive behavioral cessation counseling, Placebo Comparator: Counseling and placebo drug intervention |
| Counseling and placebo drug interventionEnhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo | Behavioural | Placebo Comparator: Counseling and placebo drug intervention |
| Counseling and active drug interventionEnhanced cue exposure treatment (lab-based + interactive SMS texting)+ active DCS. In addition to an in-person, screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit. | Drug | Active Comparator: Counseling and active drug intervention |
Primary outcome
Number of Participants With Completion of at Least 2 Study Visits
Time frame: Approximately 8 weeks
Feasibility will be determined by number of participants that complete at least 2 study visits.
Number of Participants Who Rated the Intervention Acceptable
Time frame: Approximately 8 weeks
Acceptability will be determined by the number of patients rating the intervention usefulness in the experimental and control arms on a 7-point Likert scale, where 1=extremely useless and 7=extremely useful.
1 secondary outcome
Number of Participants With Validated Cessation
Time frame: 1 week post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33109394Pollak KI, Oliver JA, Pieper C, Davis JM, Gao X, Noonan D, Kennedy D, Granados I, Fish LJ. Cue-based treatment for light smokers: A proof of concept pilot. Addict Behav. 2021 Mar;114:106717. doi: 10.1016/j.addbeh.2020.106717. Epub 2020 Oct 17.
- 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.
Kathryn Pollak, PhD 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 3 study testing Cognitive behavioral cessation counseling and Counseling and active drug intervention in people with Tobacco Use Cessation, 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 6 inclusion and 36 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 29 Mar 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 24 Feb 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?
Number of Participants With Completion of at Least 2 Study Visits (time frame: Approximately 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03416621, which also lists 1 linked publication.
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 29 Mar 2021.