Cannabis UsePhase 2NCT03766971
Influence of Tobacco Use on Cannabis Use
A Phase 2 study testing 7 days of Tobacco Cessation, 21 days of Tobacco Cessation and Cannabis in people with Cannabis Use and Tobacco Use, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
Cannabis smokers who also smoke tobacco cigarettes have markedly higher rates of cannabis relapse relative to those who do not use tobacco. There is a clear need to develop and evaluate interventions for dual tobacco and cannabis users. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use, Tobacco Use
- What is being tested?
- 7 days of Tobacco Cessation, 21 days of Tobacco Cessation and Cannabis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 30 Nov 2028
- Phase
- Phase 2
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and non-pregnant females aged 18-60 years old
- Use cannabis
- Smoke tobacco cigarettes
- Medically and psychologically healthy
Who cannot join
- Regular drug use other than cannabis
- Current pregnancy/lactation
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Cannabis smokers who also smoke tobacco cigarettes have markedly higher rates of cannabis relapse relative to those who do not use tobacco. There is a clear need to develop and evaluate interventions for dual tobacco and cannabis users. The investigators of this study have previously shown that the co-use of tobacco cigarettes contributes to the maintenance of daily cannabis use, and that age of cigarette onset is a critical predictor of treatment outcome. Short-term tobacco cessation may suffice in altering cannabis relapse rates in later-onset cigarette smokers, while a longer period of tobacco cessation may be needed for earlier-onset smokers. In the current study, a human laboratory model will be utilized to determine whether cannabis relapse varies as a function of tobacco cessation duration and age of tobacco use onset.
- Conditions
- Cannabis Use, Tobacco Use
- Being tested
- 7 days of Tobacco Cessation, 21 days of Tobacco Cessation, Cannabis
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7 days of Tobacco CessationBehavioural
Also called Early onset
Participants will be randomly assigned to 7 days of tobacco cessation.
21 days of Tobacco CessationBehavioural
Also called Late onset
Participants will be randomly assigned to 21 days of tobacco cessation.
CannabisDrug
Participants will receive cannabis.
| Study group | Role | What they receive |
|---|---|---|
| Early-onset Cigarette Smokers | Experimental | Participants who began smoking cigarettes earlier in life (<16 years old) will be randomized to 7 or 21 days of tobacco cessation. Receives: Behavioral: 7 days of Tobacco Cessation; Behavioral: 21 days of Tobacco Cessation; Drug: Cannabis |
| Late-onset Cigarette Smokers | Experimental | Participants who began smoking cigarettes later in life (>16 years old) will be randomized to 7 or 21 days of tobacco cessation. Receives: Behavioral: 7 days of Tobacco Cessation; Behavioral: 21 days of Tobacco Cessation; Drug: Cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cannabis self-administration
Number of cannabis cigarettes participant chooses to smoke.
Measured: During 9-day inpatient phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start1 Feb 2020
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2028 (estimated)
Why it stopped: In response to quality assurance and compliance concerns, OHRP issued an FWA restriction on NYSPI research that included a pause of human research as of June 23, 2023.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis UseStudies 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The effects of 7- and 21-days of tobacco cessation on cannabis relapse in daily cigarette-smoking, cannabis smokers will be compared, with half the participants in each group initiating tobacco cigarette smoking early (\<16 years) and the other half later (\>=16 years).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Margaret Haney, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766971
- Sponsor's protocol ID
- 7707
- Status last verified
- Aug 2026
- First submitted
- 4 Dec 2018
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Tobacco Use on Cannabis Use
- ClinicalTrials.gov ID
- NCT03766971
- Acronym / sponsor ID
- 7707
- Conditions
- Cannabis Use, Tobacco Use
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: In response to quality assurance and compliance concerns, OHRP issued an FWA restriction on NYSPI research that included a pause of human research as of June 23, 2023.
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 6 Dec 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.
Cannabis smokers who also smoke tobacco cigarettes have markedly higher rates of cannabis relapse relative to those who do not use tobacco. There is a clear need to develop and evaluate interventions for dual tobacco and cannabis users. The investigators of this study have previously shown that the co-use of tobacco cigarettes contributes to the maintenance of daily cannabis use, and that age of cigarette onset is a critical predictor of treatment outcome. Short-term tobacco cessation may suffice in altering cannabis relapse rates in later-onset cigarette smokers, while a longer period of tobacco cessation may be needed for earlier-onset smokers. In the current study, a human laboratory model will be utilized to determine whether cannabis relapse varies as a function of tobacco cessation duration and age of tobacco use onset.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The effects of 7- and 21-days of tobacco cessation on cannabis relapse in daily cigarette-smoking, cannabis smokers will be compared, with half the participants in each group initiating tobacco cigarette smoking early (<16 years) and the other half later (>=16 years).
| Arm | Type | Receives |
|---|---|---|
| Early-onset Cigarette Smokers | Experimental | Behavioral: 7 days of Tobacco Cessation, Behavioral: 21 days of Tobacco Cessation, Drug: CannabisParticipants who began smoking cigarettes earlier in life (<16 years old) will be randomized to 7 or 21 days of tobacco cessation. |
| Late-onset Cigarette Smokers | Experimental | Behavioral: 7 days of Tobacco Cessation, Behavioral: 21 days of Tobacco Cessation, Drug: CannabisParticipants who began smoking cigarettes later in life (>16 years old) will be randomized to 7 or 21 days of tobacco cessation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males and non-pregnant females aged 18-60 years old
- Use cannabis
- Smoke tobacco cigarettes
- Medically and psychologically healthy
Key exclusion criteria (2 listed)
- Regular drug use other than cannabis
- Current pregnancy/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 |
|---|---|---|
| 7 days of Tobacco CessationAlso: Early onsetParticipants will be randomly assigned to 7 days of tobacco cessation. | Behavioural | Early-onset Cigarette Smokers, Late-onset Cigarette Smokers |
| 21 days of Tobacco CessationAlso: Late onsetParticipants will be randomly assigned to 21 days of tobacco cessation. | Behavioural | Early-onset Cigarette Smokers, Late-onset Cigarette Smokers |
| CannabisParticipants will receive cannabis. | Drug | Early-onset Cigarette Smokers, Late-onset Cigarette Smokers |
Primary outcome
Cannabis self-administration
Time frame: During 9-day inpatient phase
Number of cannabis cigarettes participant chooses to smoke.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 7 days of Tobacco Cessation, 21 days of Tobacco Cessation and Cannabis in people with Cannabis Use and Tobacco Use, run by New York State Psychiatric Institute 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 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: paused, as of the sponsor's last update on 1 Sep 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Cannabis self-administration (time frame: During 9-day inpatient phase). 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 1 Sep 2026.