Substance Withdrawal SyndromePhase 4NCT02108626
Electronic Cigarettes in Daily Dependent Smokers
A Phase 4 study testing Nicotine in people with Substance Withdrawal Syndrome and Nicotine Dependence, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The aim of this study is to measure nicotine cue- and withdrawal-induced craving in current smokers under four distinct conditions: after smoking a conventional cigarette, an electronic cigarette (e-Cigarette) containing nicotine, an e-Cigarette without nicotine, and after taking a nicotine lozenge. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Substance Withdrawal Syndrome, Nicotine Dependence
- What is being tested?
- Nicotine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2014to Apr 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current daily smoker
- Smoke minimum of 10 cigarettes per day
- Fagerstrom Test of Nicotine Dependence Score equal or greater than 3
- Never used an e-Cigarette prior to the study
- No intention to quit smoking within the next 3 months
- Able to provide written informed consent
- Able and willing to attend scheduled appointments
Who cannot join
- Any serious medical or unstable psychiatric problems requiring treatment
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Addiction and Mental Health, BACDRL Lab
Toronto, Ontario, M5S 2S1
About this study
Official title: A Behavioral Assessment of Electronic Cigarettes in Reducing Cue- and Withdrawal-induced Craving in Daily Dependent Smokers
The aim of this study is to measure nicotine cue- and withdrawal-induced craving in current smokers under four distinct conditions: after smoking a conventional cigarette, an electronic cigarette (e-Cigarette) containing nicotine, an e-Cigarette without nicotine, and after taking a nicotine lozenge. Participants will be asked to attend four morning study visits after overnight smoking abstinence. Standardized questionnaires will be used to assess changes under each condition, allowing for the investigation of the efficacy of e-Cigarettes in reducing craving by replacing the behavioral component of smoking with minimal risk of adverse effects.
Read the detailed description
Many addiction models postulate stimuli to be linked with nicotine intake and reward after prolonged use. As such, smoking becomes more heavily based in habit, initiated by cues. Craving has been found to be a crucial component of continued smoking and relapse in response to various environmental and behavioral cues. Electronic Cigarettes (e-Cigarettes) are new smoking products emerging in consumer markets that often mimic conventional tobacco cigarettes. E-Cigarettes commonly include a cartridge, a heating element, a puff sensor, and a battery. When a user draws on the device, the heating element is activated and the cartridge fluid is vaporized. Users then inhale the aerosol containing droplets of the vaporized fluid. This study will empirically assess the efficacy of e-Cigarettes in alleviating craving by replacing the behavioral component of smoking. Using standardized questionnaires, intra-subject changes in cue- and withdrawal-induced craving after smoking an e-Cigarette without nicotine will be compared with that after either smoking a conventional cigarette, an e-Cigarette with nicotine, or taking a 4mg lozenge.
- Conditions
- Substance Withdrawal Syndrome, Nicotine Dependence
- Being tested
- Nicotine, Placebo
- Keywords
- Electronic Cigarettes, Lozenge, Nicotine, Tobacco, Dependence, Withdrawal
- Medical subject headings
- Substance Withdrawal Syndrome, Tobacco Use Disorder, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicotineDrug
E-Cigarette with nicotine cartridge
PlaceboDrug
E-Cigarette with 0mg nicotine cartridge
| Study group | Role | What they receive |
|---|---|---|
| E-Cigarette with nicotine | Active comparator | Electronic cigarette with cartridge fluid containing nicotine Receives: Drug: Nicotine |
| E-Cigarette without nicotine | Placebo comparator | Electronic cigarette with cartridge fluid containing no nicotine (placebo) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cue-induced nicotine craving
Craving assessment after presentation of smoking- and neutral-cues 1 hour after condition
Measured: 1 hour after condition
Secondary outcomes (1)
Withdrawal-induced nicotine craving
Craving assessment after presentation of smoking- and neutral-cues 3 hours after condition
Measured: 3 hours after condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Withdrawal SyndromeStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurie Zawertailo, Centre for Addiction and Mental Health
- Investigators
- Laurie Zawertailo, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108626
- Sponsor's protocol ID
- 001/2014
- Status last verified
- May 2015
- First submitted
- 7 Apr 2014
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ng G, Attwells S, Selby P, Zawertailo L. Effectiveness of Non-Nicotinic E-Cigarettes to Reduce Cue- and Abstinence-Induced Cigarette Craving in Non-Treatment Seeking Daily Dependent Smokers. Psychopharmacology (Berl). 2021 Jun;238(6):1461-1472. doi: 10.1007/s00213-021-05772-4. Epub 2021 Jan 30.
PubMed 33515267
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Behavioral Assessment of Electronic Cigarettes in Reducing Cue- and Withdrawal-induced Craving in Daily Dependent Smokers
- ClinicalTrials.gov ID
- NCT02108626
- Acronym / sponsor ID
- 001/2014
- Conditions
- Substance Withdrawal Syndrome, Nicotine Dependence
- Keywords
- Electronic Cigarettes, Lozenge, Nicotine, Tobacco, Dependence, Withdrawal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 9 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to measure nicotine cue- and withdrawal-induced craving in current smokers under four distinct conditions: after smoking a conventional cigarette, an electronic cigarette (e-Cigarette) containing nicotine, an e-Cigarette without nicotine, and after taking a nicotine lozenge. Participants will be asked to attend four morning study visits after overnight smoking abstinence. Standardized questionnaires will be used to assess changes under each condition, allowing for the investigation of the efficacy of e-Cigarettes in reducing craving by replacing the behavioral component of smoking with minimal risk of adverse effects.
Detailed description
Many addiction models postulate stimuli to be linked with nicotine intake and reward after prolonged use. As such, smoking becomes more heavily based in habit, initiated by cues. Craving has been found to be a crucial component of continued smoking and relapse in response to various environmental and behavioral cues. Electronic Cigarettes (e-Cigarettes) are new smoking products emerging in consumer markets that often mimic conventional tobacco cigarettes. E-Cigarettes commonly include a cartridge, a heating element, a puff sensor, and a battery. When a user draws on the device, the heating element is activated and the cartridge fluid is vaporized. Users then inhale the aerosol containing droplets of the vaporized fluid. This study will empirically assess the efficacy of e-Cigarettes in alleviating craving by replacing the behavioral component of smoking. Using standardized questionnaires, intra-subject changes in cue- and withdrawal-induced craving after smoking an e-Cigarette without nicotine will be compared with that after either smoking a conventional cigarette, an e-Cigarette with nicotine, or taking a 4mg lozenge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-Cigarette with nicotine | Active comparator | Drug: NicotineElectronic cigarette with cartridge fluid containing nicotine |
| E-Cigarette without nicotine | Placebo comparator | Drug: PlaceboElectronic cigarette with cartridge fluid containing no nicotine (placebo) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Current daily smoker
- Smoke minimum of 10 cigarettes per day
- Fagerstrom Test of Nicotine Dependence Score equal or greater than 3
- Never used an e-Cigarette prior to the study
- No intention to quit smoking within the next 3 months
Key exclusion criteria (2 listed)
- Any serious medical or unstable psychiatric problems requiring treatment
- Pregnancy or lactation
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 |
|---|---|---|
| NicotineE-Cigarette with nicotine cartridge | Drug | E-Cigarette with nicotine |
| PlaceboE-Cigarette with 0mg nicotine cartridge | Drug | E-Cigarette without nicotine |
Primary outcome
Cue-induced nicotine craving
Time frame: 1 hour after condition
Craving assessment after presentation of smoking- and neutral-cues 1 hour after condition
1 secondary outcome
Withdrawal-induced nicotine craving
Time frame: 3 hours after condition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
- Derived from this study: PubMed 33515267Ng G, Attwells S, Selby P, Zawertailo L. Effectiveness of Non-Nicotinic E-Cigarettes to Reduce Cue- and Abstinence-Induced Cigarette Craving in Non-Treatment Seeking Daily Dependent Smokers. Psychopharmacology (Berl). 2021 Jun;238(6):1461-1472. doi: 10.1007/s00213-021-05772-4. Epub 2021 Jan 30.
- Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital. It is fully affiliated with the University of Toronto, and is a PAHO/WHO Collaborating CentreLink provided by the sponsor.
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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.
Laurie Zawertailo, PhD principal investigator
Centre for Addiction and Mental Health
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 Nicotine in people with Substance Withdrawal Syndrome and Nicotine Dependence, run by Centre for Addiction and Mental Health at 1 site in Canada.
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 2 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 5 May 2015. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cue-induced nicotine craving (time frame: 1 hour after condition). 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 NCT02108626, 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 5 May 2015.