Tobacco Use DisorderNCT02888249
Behavioral Economic Purchasing Decisions for Cigarettes of Varied Compositions
A study testing Altered composition cigarette in people with Tobacco Use Disorder and Substance-Related Disorders, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the abuse liability of cigarettes with altered composition (cigarettes differing in composition; e.g., tar levels, amount of sugar, casings) is reduced relative to standard composition cigarettes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Disorder, Substance-Related Disorders
- What is being tested?
- Altered composition cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2017to 10 Nov 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Smoke at least five cigarettes per day
- Have an expired carbon monoxide level of more than 8 ppm or a urinary cotinine level of more than 100 ng per milliliter
- Have a Fagerström Test for Nicotine Dependence score of at least 5 upon screening
Who cannot join
- The intention to quit smoking in the next 30 days
- The use of other tobacco products in addition to machine-manufactured cigarettes on more than 9 of the previous 30 days
- Use of "roll your own" cigarettes as an exclusive form of smoking
- A serious medical or psychiatric disorder or unstable condition
- Any positive toxicological screening for illicit drugs other than cannabis will be excluded
- Women who are pregnant, plan to become pregnant or are breast-feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine, Bayview Campus
Baltimore, Maryland, 21224
About this study
The purpose of this study is to determine whether the abuse liability of cigarettes with altered composition (cigarettes differing in composition; e.g., tar levels, amount of sugar, casings) is reduced relative to standard composition cigarettes.
Read the detailed description
The proposed study will determine the abuse liability of altered composition cigarettes compared to standard cigarettes using a behavioral economics abuse-liability approach. Behavioral economic demand analysis constitutes a comprehensive examination of drug reinforcement and abuse liability. Laboratory determination of cigarette consumption under various response requirements will occur before and after 3 weeks of at-home exposure, with participants randomized to cigarettes varying in composition to determine the role of experience on the abuse-liability of various cigarettes. Abuse liability will be assessed by 2 essential demand metrics: lower demand intensity and increased demand elasticity, as well as other demand metrics and subjective ratings of "liking". The study will also determine the degree to which altered composition cigarettes may substitute for standard composition cigarettes - testing whether an altered composition policy would achieve the goal of reducing standard cigarette consumption.
- Conditions
- Tobacco Use Disorder, Substance-Related Disorders
- Being tested
- Altered composition cigarette
- Keywords
- Tobacco withdrawal, Autonomic Agents
- Medical subject headings
- Tobacco Use Disorder, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Altered composition cigaretteOther
This double-blind study will systematically determine the abuse liability of altered composition cigarettes using a behavioral economics abuse-liability approach. Altered composition cigarettes (e.g., cigarettes differing in casings, sugars, tar levels, moisture) may result in decreased intake and decreased dependence, although critical questions remain regarding the abuse-liability of altered composition cigarettes, whether exposure to these cigarettes reduces use, and whether altered composition cigarettes will substitute for standard cigarettes. The addictive effects and abuse liability of altered composition cigarettes, therefore, are not well understood, and will be tested in this study.
| Study group | Role | What they receive |
|---|---|---|
| Cigarette W | Experimental | Altered composition cigarettes
moisture = 12.20 %, tar = 10.40 mg/cigarette, total particulate matter = 12.0 mg/cigarette, high sugar content Receives: Other: Altered composition cigarette |
| Cigarette X | Experimental | Altered composition cigarettes
moisture = 12.10 %, tar = 8.60 mg/cigarette, total particulate matter = 9.60 mg/cigarette, low sugar content Receives: Other: Altered composition cigarette |
| Cigarette Y | Experimental | Altered composition cigarettes
moisture = 13.20 %, tar = 9.10 mg/cigarette, total particulate matter = 10.10 mg/cigarette, low sugar content Receives: Other: Altered composition cigarette |
| Cigarette Z | Experimental | Altered composition cigarettes
moisture = 13.60 %, tar = 8.10 mg/cigarette, total particulate matter = 9.10 mg/cigarette, low sugar content Receives: Other: Altered composition cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demand Intensity: Number of cigarette puffs obtained at the lowest fixed ratio value
The primary behavioral economic demand curve metric (demand intensity, i.e., number of cigarette puffs obtained at the lowest fixed ratio value assessed) derived from cigarette consumption in the laboratory
Measured: 3 weeks after initiation of home exposure period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study start25 Aug 2017
- Primary completion10 Nov 2021
- Study completion10 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Matthew W Johnson, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888249
- Sponsor's protocol ID
- IRB00107178
- Other IDs
- 5R01DA042527
- Status last verified
- Jan 2021
- First submitted
- 23 Aug 2016
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Economic Purchasing Decisions for Cigarettes of Varied Compositions
- ClinicalTrials.gov ID
- NCT02888249
- Acronym / sponsor ID
- IRB00107178
- Conditions
- Tobacco Use Disorder, Substance-Related Disorders
- Keywords
- Tobacco withdrawal, Autonomic Agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 25 Aug 2017 (actual)
- Primary completion
- 10 Nov 2021 (actual)
- Study completion
- 10 Nov 2021 (actual)
- First posted
- 2 Sep 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 determine whether the abuse liability of cigarettes with altered composition (cigarettes differing in composition; e.g., tar levels, amount of sugar, casings) is reduced relative to standard composition cigarettes.
Detailed description
The proposed study will determine the abuse liability of altered composition cigarettes compared to standard cigarettes using a behavioral economics abuse-liability approach. Behavioral economic demand analysis constitutes a comprehensive examination of drug reinforcement and abuse liability. Laboratory determination of cigarette consumption under various response requirements will occur before and after 3 weeks of at-home exposure, with participants randomized to cigarettes varying in composition to determine the role of experience on the abuse-liability of various cigarettes. Abuse liability will be assessed by 2 essential demand metrics: lower demand intensity and increased demand elasticity, as well as other demand metrics and subjective ratings of "liking". The study will also determine the degree to which altered composition cigarettes may substitute for standard composition cigarettes - testing whether an altered composition policy would achieve the goal of reducing standard cigarette consumption.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cigarette W | Experimental | Other: Altered composition cigaretteAltered composition cigarettes moisture = 12.20 %, tar = 10.40 mg/cigarette, total particulate matter = 12.0 mg/cigarette, high sugar content |
| Cigarette X | Experimental | Other: Altered composition cigaretteAltered composition cigarettes moisture = 12.10 %, tar = 8.60 mg/cigarette, total particulate matter = 9.60 mg/cigarette, low sugar content |
| Cigarette Y | Experimental | Other: Altered composition cigaretteAltered composition cigarettes moisture = 13.20 %, tar = 9.10 mg/cigarette, total particulate matter = 10.10 mg/cigarette, low sugar content |
| Cigarette Z | Experimental | Other: Altered composition cigaretteAltered composition cigarettes moisture = 13.60 %, tar = 8.10 mg/cigarette, total particulate matter = 9.10 mg/cigarette, low sugar content |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Smoke at least five cigarettes per day
- Have an expired carbon monoxide level of more than 8 ppm or a urinary cotinine level of more than 100 ng per milliliter
- Have a Fagerström Test for Nicotine Dependence score of at least 5 upon screening
Key exclusion criteria (6 listed)
- The intention to quit smoking in the next 30 days
- The use of other tobacco products in addition to machine-manufactured cigarettes on more than 9 of the previous 30 days
- Use of "roll your own" cigarettes as an exclusive form of smoking
- A serious medical or psychiatric disorder or unstable condition
- Any positive toxicological screening for illicit drugs other than cannabis will be excluded
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 |
|---|---|---|
| Altered composition cigaretteThis double-blind study will systematically determine the abuse liability of altered composition cigarettes using a behavioral economics abuse-liability approach. Altered composition cigarettes (e.g., cigarettes differing in casings, sugars, tar levels, moisture) may result in decreased intake and decreased dependence, although critical questions remain regarding the abuse-liability of altered composition cigarettes, whether exposure to these cigarettes reduces use, and whether altered composition cigarettes will substitute for standard cigarettes. The addictive effects and abuse liability of altered composition cigarettes, therefore, are not well understood, and will be tested in this study. | Other | Cigarette W, Cigarette X, Cigarette Y, Cigarette Z |
Primary outcome
Demand Intensity: Number of cigarette puffs obtained at the lowest fixed ratio value
Time frame: 3 weeks after initiation of home exposure period
The primary behavioral economic demand curve metric (demand intensity, i.e., number of cigarette puffs obtained at the lowest fixed ratio value assessed) derived from cigarette consumption in the laboratory
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 18 Oct 2022.
- 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.
Matthew W Johnson, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Altered composition cigarette in people with Tobacco Use Disorder and Substance-Related Disorders, run by Johns Hopkins 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 4 inclusion and 6 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 18 Oct 2022. 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. 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?
Demand Intensity: Number of cigarette puffs obtained at the lowest fixed ratio value (time frame: 3 weeks after initiation of home exposure period). 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 18 Oct 2022.