Smoking, TobaccoPhase 1NCT03651869
Effects of Nicotine in Tobacco Smokers
A Phase 1 study testing Cigarette 1, Cigarette 2 and Patch 1 in people with Smoking, Tobacco and Smoking (Tobacco) Addiction, run by University of Southern California at 1 site in United States.
Trial summary
This study will examine mechanisms linking Obsessive-Compulsive Disorder symptomatology to tobacco dependence. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Tobacco, Smoking (Tobacco) Addiction
- What is being tested?
- Cigarette 1, Cigarette 2 and Patch 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2019to 23 Mar 2023
- Phase
- Phase 1
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 21 years old
- Daily smoking at least 2 years
Who cannot join
- Currently pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033
About this study
Official title: Mechanisms Linking Obsessive-Compulsive Symptoms and Tobacco Dependence
This study will examine mechanisms linking Obsessive-Compulsive Disorder symptomatology to tobacco dependence.
- Conditions
- Smoking, Tobacco, Smoking (Tobacco) Addiction
- Being tested
- Cigarette 1, Cigarette 2, Patch 1, Patch 2
- Keywords
- Smoking
- Medical subject headings
- Tobacco Smoking, Smoking, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cigarette 1Drug
Cigarette containing between 0mg nicotine and the conventional amount of nicotine (0.8mg)
Cigarette 2Drug
Cigarette containing between 0mg nicotine and the conventional amount of nicotine (0.8mg)
Patch 1Drug
A patch containing between 0mg nicotine and the conventional amount of nicotine (21mg)
Patch 2Drug
A patch containing between 0mg nicotine and the conventional amount of nicotine (21mg)
| Study group | Role | What they receive |
|---|---|---|
| Condition 1 | Experimental | Not described Receives: Drug: Cigarette 1; Drug: Patch 1 |
| Condition 2 | Experimental | Not described Receives: Drug: Cigarette 2; Drug: Patch 1 |
| Condition 3 | Experimental | Not described Receives: Drug: Cigarette 1; Drug: Patch 2 |
| Condition 4 | Experimental | Not described Receives: Drug: Cigarette 2; Drug: Patch 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Urge
Smoking urge is measured using questionnaires that ask about a desire to smoke.
Measured: Throughout study completion, an average of two weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start4 Feb 2019
- Primary completion23 Mar 2023
- Study completion23 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking, TobaccoStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Illinois Institute of Technology
- Responsible party
- Principal investigator, Adam Leventhal, University of Southern California
- Investigators
- Adam M Leventhal, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651869
- Sponsor's protocol ID
- 28IR-0063
- Status last verified
- Jul 2023
- First submitted
- 23 Aug 2018
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms Linking Obsessive-Compulsive Symptoms and Tobacco Dependence
- ClinicalTrials.gov ID
- NCT03651869
- Acronym / sponsor ID
- 28IR-0063
- Conditions
- Smoking, Tobacco, Smoking (Tobacco) Addiction
- Keywords
- Smoking
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Illinois Institute of Technology
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 29 Aug 2018 (actual)
- 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.
This study will examine mechanisms linking Obsessive-Compulsive Disorder symptomatology to tobacco dependence.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Condition 1 | Experimental | Drug: Cigarette 1, Drug: Patch 1 |
| Condition 2 | Experimental | Drug: Cigarette 2, Drug: Patch 1 |
| Condition 3 | Experimental | Drug: Cigarette 1, Drug: Patch 2 |
| Condition 4 | Experimental | Drug: Cigarette 2, Drug: Patch 2 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 21 years old
- Daily smoking at least 2 years
Key exclusion criteria (1 listed)
- Currently pregnant or breastfeeding.
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 |
|---|---|---|
| Cigarette 1Cigarette containing between 0mg nicotine and the conventional amount of nicotine (0.8mg) | Drug | Condition 1, Condition 3 |
| Cigarette 2Cigarette containing between 0mg nicotine and the conventional amount of nicotine (0.8mg) | Drug | Condition 2, Condition 4 |
| Patch 1A patch containing between 0mg nicotine and the conventional amount of nicotine (21mg) | Drug | Condition 1, Condition 2 |
| Patch 2A patch containing between 0mg nicotine and the conventional amount of nicotine (21mg) | Drug | Condition 3, Condition 4 |
Primary outcome
Smoking Urge
Time frame: Throughout study completion, an average of two weeks.
Smoking urge is measured using questionnaires that ask about a desire to smoke.
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 13 Jul 2023.
- 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.
Adam M Leventhal, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cigarette 1, Cigarette 2 and Patch 1 in people with Smoking, Tobacco and Smoking (Tobacco) Addiction, run by University of Southern California 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 2 inclusion and 1 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 13 Jul 2023. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Smoking Urge (time frame: Throughout study completion, an average of two weeks.). 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 13 Jul 2023.