Tobacco UsePhase 1MJCIGNCT02961309
A Laboratory Model of Increasing Delta-9-tetrahydrocannabinol (THC) Potency on Cigarette Smoking
A Phase 1 study testing THC in people with Tobacco Use, run by Battelle Memorial Institute at 1 site in United States.
Trial summary
The objective of the proposed research is to investigate how smoking increasing potency of THC (i.e., the psychoactive ingredient in marijuana) changes tobacco cigarette smoking behavior, urges, subjective effects, and abuse liability. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use
- What is being tested?
- THC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2018to 30 Sep 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current US resident;
- Age ≥ 18 years;
- Self-reported smoking of marijuana no more than three days per week within the past year;
- Self-report past-month smoking of marijuana;
- Self-report daily smoking of at least five cigarettes per day within the past year;
- Cotinine ≥ 100 ng/mL at the in-person screening visit; and
- Able to read, understand, and sign informed consent.
Who cannot join
- Meets Diagnostic and Statistical Manual-5 (DSM-5) criteria for current (i.e., past year) or past (i.e., lifetime) cannabis use disorder;
- Meets DSM-5 criteria for any current Axis I disorder, other than tobacco use disorder;
- Self-reported current desire to stop marijuana or tobacco use, defined as 7 or greater on an 11-rung (scaled of 1-10) Contemplation Ladder for each;
- Self-reported asthma or chronic obstructive pulmonary disease; and
- Among females, current pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Battelle Memorial Institute
Baltimore, Maryland, 21209
About this study
Official title: A Laboratory Model of Increasing THC Potency on Cigarette Smoking
The objective of the proposed research is to investigate how smoking increasing potency of THC (i.e., the psychoactive ingredient in marijuana) changes tobacco cigarette smoking behavior, urges, subjective effects, and abuse liability. This study will be a within-subjects, placebo-controlled study in our clinical laboratory of the effect of active vs. placebo marijuana on cigarette puff topography, exhaled carbon monoxide, urge, subjective effects, and abuse liability among 7 adults who smoke both marijuana and tobacco cigarettes.
Read the detailed description
The study requires a total of three visits to Battelle's laboratory: one screening visit and two experimental visits. The screening visit will determine eligibility into the study. If eligible, participants will smoke a tobacco cigarette through the Clinical Research Support System (CReSS) puff topography device. Enrolled participants will attend two separate 5-hour experimental visits. Participants will be randomly assigned the order of THC potency (active or placebo), with the assignment blocked by sex. When participants arrive at the laboratory for each visit, they will provide biologic samples to verify compliance with pre-study instructions and then will be taken to a specially ventilated smoking chamber. They will be connected to a continuously-monitoring heart rate and blood pressure machine so that their vital signs can be observed throughout the smoking session. A research assistant will give a marijuana cigarette to the participant. A research assistant will light the cigarette and then exit the room. Participants will follow tape-recorded instructions for smoking the marijuana cigarette through the CReSS device. Upon completion of smoking the marijuana cigarette, participants will complete the Tobacco Craving Questionnaire via paper and pencil and will then be allowed to smoke one of his own tobacco cigarettes through the CReSS puff topography device. Participants will be allowed to smoke as many tobacco cigarettes as they would like for the next 3 hours. Participants will then be given lunch and sent home via taxicab. All participants will receive both potencies (i.e., active and placebo) of marijuana. The active potency of marijuana will be 5.6% THC.
- Conditions
- Tobacco Use
- Being tested
- THC
- Keywords
- THC, marijuana, tobacco cigarette, smoking
- Medical subject headings
- Tobacco Use, Marijuana Abuse, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THCDrug
Also called marijuana
1 High-Potency THC (Dosage = 10mg) cigarette (oral smoking) on one day and 1 Placebo on the other day.
| Study group | Role | What they receive |
|---|---|---|
| Active THC | Experimental | 5.6% THC via smoked marijuana cigarette Receives: Drug: THC |
| Placebo | Experimental | Placebo THC via smoked cigarette Receives: Drug: THC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Puff topography of tobacco cigarette smoked
Mean total puff volume
Measured: 30 minutes post-marijuana smoking
Secondary outcomes (3)
Boost in exhaled breath carbon monoxide after smoking tobacco cigarette
Pre- to post-tobacco cigarette smoking difference in exhaled breath carbon monoxide
Measured: 30 minutes post-marijuana smoking
Self-reported urge to smoke tobacco cigarette
Pre- to post-tobacco cigarette smoking difference in scores on the Questionnaire of Smoking Urge
Measured: 30 minutes post marijuana smoking
Self-reported subjective effects related to tobacco cigarette smoking
Pre- to post-tobacco cigarette smoking difference in the Nicotine-Drug Effects Questionnaire
Measured: 30 minutes post marijuana smoking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2016 (estimated)
- Study start7 May 2018
- Primary completion24 Apr 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Battelle Memorial Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wallace Pickworth, PhD, Principal investigator, Battelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961309
- Sponsor's protocol ID
- BMI-73659
- Acronym
- MJCIG
- Status last verified
- Sep 2019
- First submitted
- 2 Nov 2016
- Last updated
- 2 Oct 2019
- 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 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Laboratory Model of Increasing THC Potency on Cigarette Smoking
- ClinicalTrials.gov ID
- NCT02961309
- Acronym / sponsor ID
- MJCIG / BMI-73659
- Conditions
- Tobacco Use
- Keywords
- THC, marijuana, tobacco cigarette, smoking
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Battelle Memorial InstituteUniversity, hospital or other
- Study start
- 7 May 2018 (actual)
- Primary completion
- 24 Apr 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 10 Nov 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 objective of the proposed research is to investigate how smoking increasing potency of THC (i.e., the psychoactive ingredient in marijuana) changes tobacco cigarette smoking behavior, urges, subjective effects, and abuse liability. This study will be a within-subjects, placebo-controlled study in our clinical laboratory of the effect of active vs. placebo marijuana on cigarette puff topography, exhaled carbon monoxide, urge, subjective effects, and abuse liability among 7 adults who smoke both marijuana and tobacco cigarettes.
Detailed description
The study requires a total of three visits to Battelle's laboratory: one screening visit and two experimental visits. The screening visit will determine eligibility into the study. If eligible, participants will smoke a tobacco cigarette through the Clinical Research Support System (CReSS) puff topography device. Enrolled participants will attend two separate 5-hour experimental visits. Participants will be randomly assigned the order of THC potency (active or placebo), with the assignment blocked by sex. When participants arrive at the laboratory for each visit, they will provide biologic samples to verify compliance with pre-study instructions and then will be taken to a specially ventilated smoking chamber. They will be connected to a continuously-monitoring heart rate and blood pressure machine so that their vital signs can be observed throughout the smoking session. A research assistant will give a marijuana cigarette to the participant. A research assistant will light the cigarette and then exit the room. Participants will follow tape-recorded instructions for smoking the marijuana cigarette through the CReSS device. Upon completion of smoking the marijuana cigarette, participants will complete the Tobacco Craving Questionnaire via paper and pencil and will then be allowed to smoke one of his own tobacco cigarettes through the CReSS puff topography device. Participants will be allowed to smoke as many tobacco cigarettes as they would like for the next 3 hours. Participants will then be given lunch and sent home via taxicab. All participants will receive both potencies (i.e., active and placebo) of marijuana. The active potency of marijuana will be 5.6% THC.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active THC | Experimental | Drug: THC5.6% THC via smoked marijuana cigarette |
| Placebo | Experimental | Drug: THCPlacebo THC via smoked cigarette |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Current US resident;
- Age ≥ 18 years;
- Self-reported smoking of marijuana no more than three days per week within the past year;
- Self-report past-month smoking of marijuana;
- Self-report daily smoking of at least five cigarettes per day within the past year;
Key exclusion criteria (5 listed)
- Meets Diagnostic and Statistical Manual-5 (DSM-5) criteria for current (i.e., past year) or past (i.e., lifetime) cannabis use disorder;
- Meets DSM-5 criteria for any current Axis I disorder, other than tobacco use disorder;
- Self-reported current desire to stop marijuana or tobacco use, defined as 7 or greater on an 11-rung (scaled of 1-10) Contemplation Ladder for each;
- Self-reported asthma or chronic obstructive pulmonary disease; and
- Among females, current 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 |
|---|---|---|
| THCAlso: marijuana1 High-Potency THC (Dosage = 10mg) cigarette (oral smoking) on one day and 1 Placebo on the other day. | Drug | Active THC, Placebo |
Primary outcome
Puff topography of tobacco cigarette smoked
Time frame: 30 minutes post-marijuana smoking
Mean total puff volume
3 secondary outcomes
Boost in exhaled breath carbon monoxide after smoking tobacco cigarette
Time frame: 30 minutes post-marijuana smoking
Self-reported urge to smoke tobacco cigarette
Time frame: 30 minutes post marijuana smoking
Self-reported subjective effects related to tobacco cigarette smoking
Time frame: 30 minutes post marijuana smoking
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 2 Oct 2019.
- 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.
Wallace Pickworth, PhD principal investigator
Battelle
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 THC in people with Tobacco Use, run by Battelle Memorial 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 7 inclusion and 5 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 2 Oct 2019. 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?
Puff topography of tobacco cigarette smoked (time frame: 30 minutes post-marijuana smoking). 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 2 Oct 2019.