Substance Withdrawal SyndromeNCT02825459
Does Abstinence From E-cigarettes Produce Withdrawal Symptoms?
A study testing Abstinence from e-cigarettes in people with Substance Withdrawal Syndrome, run by University of Vermont at 2 sites in United States.
Trial summary
The purpose of this study is to see whether adults who use e-cigarettes every day experience symptoms of nicotine withdrawal when they stop using e-cigarettes for 6 days. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Withdrawal Syndrome
- What is being tested?
- Abstinence from e-cigarettes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2016to 31 Oct 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Able to read and understand verbal English fluently
- US citizen or resident alien
- Primarily uses e-cigarette product types of refillable tanks or modified devices
- Uses nicotine-containing e-liquid
- Has baseline urinary cotinine concentration of > 100 ng/ml
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- Has used e-cigarettes daily for the last 2 months
- Has a home or cell phone
- Agrees to abstain from tobacco, marijuana and other illegal drugs during study
Who cannot join
- Smoked > 5 tobacco cigarettes in the last month
- Used non-cigarette nicotine, tobacco or quit smoking products on >5 days in the past month
- Use of cannabis (either marijuana or synthetic cannabis) > 5 times in the past month or positive test for cannabis use at screening
- Current (last 6 months) Generalized Anxiety Disorder, Major Depressive Disorder, Attention Deficit Hyperactivity Disorder or moderate/severe Substance Abuse Disorder
- Multiple legal, social health, work or school problems in the past month due to alcohol or drug use
- Pregnant or breastfeeding
Show all 9Show fewer
- Previously a participant in the current study
- Use of prescribed or non-prescribed psychoactive medication > 5 times in the past month
- Expired carbon monoxide level > 8ppm
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Battelle Memorial Institute
Baltimore, Maryland, 21209
University of Vermont
Burlington, Vermont, 05401
About this study
The purpose of this study is to see whether adults who use e-cigarettes every day experience symptoms of nicotine withdrawal when they stop using e-cigarettes for 6 days.
Read the detailed description
Study Design: The investigators will recruit 120 individuals who are long-term daily and exclusive users of nicotine-containing e-cigarettes. Participants will be asked to use their own e-cigarette as usual during the first week of the study and to then stop their use of e-cigarettes for 6 days. The total study duration will be 14 days. Participants will be instructed to continue abstinence from other tobacco and nicotine products during the entire study. The investigators will use an escalating payment system with bonuses based on breath and urine samples to encourage compliance.
Every day during the study, participants will report e-cigarette and tobacco cigarette use and monitor symptoms of nicotine withdrawal via a phone call to an Interactive Voice Response system. Participants will attend 3 study visits each week to provide urine and breath samples to verify compliance, and to complete brief surveys.
- Conditions
- Substance Withdrawal Syndrome
- Being tested
- Abstinence from e-cigarettes
- Keywords
- abstinence, abuse liability, electronic cigarette, e-cigarette, electronic nicotine delivery device, harm reduction, nicotine, nicotine dependence, smoking, smoking cessation, tobacco, vape, vaping, withdrawal
- Medical subject headings
- Substance Withdrawal Syndrome, Vaping, Harm Reduction, Tobacco Use Disorder, Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abstinence from e-cigarettesBehavioural
Abrupt cessation for 6 days
| Study group | Role | What they receive |
|---|---|---|
| Abstinence from e-cigarettes | Experimental | Participants abstain from e-cigarettes and other nicotine/tobacco products for 6 days Receives: Behavioral: Abstinence from e-cigarettes |
| E-cigarette use | No intervention | Participants use e-cigarettes and continue to abstain from tobacco/nicotine products as they normally would. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total score on the Minnesota Nicotine Withdrawal Scale (MNWS)
The investigators will compare the mean score across participants for the entire 6-day abstinence vs. use conditions.
Measured: 6 days
Secondary outcomes (5)
Individual items on the Minnesota Nicotine Withdrawal Scale (MNWS)
The investigators will use the mean score for each of the 16 symptoms across participants during abstinence and use conditions.
Measured: 6 days
Questionnaire of E-cigarette Urges (brief)
This is a revision of the brief version Questionnaire of Smoking Urges that asks about urges for e-cigarettes rather than tobacco cigarettes.
Measured: 6 days
Questionnaire of Smoking Urges- brief version
This 2-item scale asks about intensity and frequency of urges.
Measured: 6 days
Heart rate
Measured for 30 sec after sitting for 15 minutes
Measured: 6 days
E-cigarette Purchase Task
This is a modification of the Cigarette Purchase Task that asks how much users would expend to obtain their usual amount of e-liquids to use.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startJul 2016
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, John Hughes, University of Vermont
- Investigators
- John R Hughes, MD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825459
- Sponsor's protocol ID
- 1R01CA192940-01
- Other IDs
- R01CA192940-01
- Status last verified
- Nov 2018
- First submitted
- 28 Jun 2016
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hughes JR, Peters EN, Callas PW, Peasley-Miklus C, Oga E, Etter JF, Morley N. Withdrawal Symptoms From E-Cigarette Abstinence Among Adult Never-Smokers: A Pilot Experimental Study. Nicotine Tob Res. 2020 Apr 21;22(5):740-746. doi: 10.1093/ntr/ntz169.
PubMed 31504882Hughes JR, Peters EN, Callas PW, Peasley-Miklus C, Oga E, Etter JF, Morley N. Withdrawal Symptoms From E-Cigarette Abstinence Among Former Smokers: A Pre-Post Clinical Trial. Nicotine Tob Res. 2020 Apr 21;22(5):734-739. doi: 10.1093/ntr/ntz129.
PubMed 31352486
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Abstinence From E-cigarettes Produce Withdrawal Symptoms?
- ClinicalTrials.gov ID
- NCT02825459
- Acronym / sponsor ID
- 1R01CA192940-01
- Conditions
- Substance Withdrawal Syndrome
- Keywords
- abstinence, abuse liability, electronic cigarette, e-cigarette, electronic nicotine delivery device, harm reduction, nicotine, nicotine dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2016
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 7 Jul 2016 (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 purpose of this study is to see whether adults who use e-cigarettes every day experience symptoms of nicotine withdrawal when they stop using e-cigarettes for 6 days.
Detailed description
Study Design: The investigators will recruit 120 individuals who are long-term daily and exclusive users of nicotine-containing e-cigarettes. Participants will be asked to use their own e-cigarette as usual during the first week of the study and to then stop their use of e-cigarettes for 6 days. The total study duration will be 14 days. Participants will be instructed to continue abstinence from other tobacco and nicotine products during the entire study. The investigators will use an escalating payment system with bonuses based on breath and urine samples to encourage compliance.
Every day during the study, participants will report e-cigarette and tobacco cigarette use and monitor symptoms of nicotine withdrawal via a phone call to an Interactive Voice Response system. Participants will attend 3 study visits each week to provide urine and breath samples to verify compliance, and to complete brief surveys.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abstinence from e-cigarettes | Experimental | Behavioral: Abstinence from e-cigarettesParticipants abstain from e-cigarettes and other nicotine/tobacco products for 6 days |
| E-cigarette use | No intervention | –Participants use e-cigarettes and continue to abstain from tobacco/nicotine products as they normally would. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years or older
- Able to read and understand verbal English fluently
- US citizen or resident alien
- Primarily uses e-cigarette product types of refillable tanks or modified devices
- Uses nicotine-containing e-liquid
Key exclusion criteria (9 listed)
- Smoked > 5 tobacco cigarettes in the last month
- Used non-cigarette nicotine, tobacco or quit smoking products on >5 days in the past month
- Use of cannabis (either marijuana or synthetic cannabis) > 5 times in the past month or positive test for cannabis use at screening
- Current (last 6 months) Generalized Anxiety Disorder, Major Depressive Disorder, Attention Deficit Hyperactivity Disorder or moderate/severe Substance Abuse Disorder
- Multiple legal, social health, work or school problems in the past month due to alcohol or drug use
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 |
|---|---|---|
| Abstinence from e-cigarettesAbrupt cessation for 6 days | Behavioural | Abstinence from e-cigarettes |
Primary outcome
Total score on the Minnesota Nicotine Withdrawal Scale (MNWS)
Time frame: 6 days
The investigators will compare the mean score across participants for the entire 6-day abstinence vs. use conditions.
5 secondary outcomes
Individual items on the Minnesota Nicotine Withdrawal Scale (MNWS)
Time frame: 6 days
Questionnaire of E-cigarette Urges (brief)
Time frame: 6 days
Questionnaire of Smoking Urges- brief version
Time frame: 6 days
Heart rate
Time frame: 6 days
E-cigarette Purchase Task
Time frame: 6 days
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 20 Nov 2018.
- Derived from this study: PubMed 31504882Hughes JR, Peters EN, Callas PW, Peasley-Miklus C, Oga E, Etter JF, Morley N. Withdrawal Symptoms From E-Cigarette Abstinence Among Adult Never-Smokers: A Pilot Experimental Study. Nicotine Tob Res. 2020 Apr 21;22(5):740-746. doi: 10.1093/ntr/ntz169.
- Derived from this study: PubMed 31352486Hughes JR, Peters EN, Callas PW, Peasley-Miklus C, Oga E, Etter JF, Morley N. Withdrawal Symptoms From E-Cigarette Abstinence Among Former Smokers: A Pre-Post Clinical Trial. Nicotine Tob Res. 2020 Apr 21;22(5):734-739. doi: 10.1093/ntr/ntz129.
- 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.
John R Hughes, MD principal investigator
University of Vermont
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abstinence from e-cigarettes in people with Substance Withdrawal Syndrome, run by University of Vermont at 2 sites 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 9 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 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Total score on the Minnesota Nicotine Withdrawal Scale (MNWS) (time frame: 6 days). 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 NCT02825459, which also lists 2 linked publications.
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 20 Nov 2018.