Tobacco Use DisorderPhase 2NCT07636356
THCV Treatment for Smokers
A Phase 2 study testing Δ9-Tetrahydrocannabivarin (oral gummy) in people with Tobacco Use Disorder and Smoking Cessation, run by University of California, Los Angeles.
Trial summary
This study will randomize 32 non-treatment-seeking individuals who smoke cigarettes daily into a randomized, crossover, double-blind, placebo-controlled study testing the safety, tolerability, and initial efficacy of Δ9-tetrahydrocannabivarin (Δ9-THCV). Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Tobacco Use Disorder, Smoking Cessation
- What is being tested?
- Δ9-Tetrahydrocannabivarin (oral gummy)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to 31 May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be between the ages of 21 and 65;
- Smoke 10 or more combustible cigarettes per day;
- Have fewer than 3 months of smoking abstinence in the past year;
- Has self-reported ≥10 lifetime uses of cannabis products;
- Have self-reported recent (past 3-month) use of cannabis products;
- Agree to abstain from all other cannabinoid use during the study;
- Agree to abstain from all other medication use during the study, other than methods of birth control as listed in inclusion criteria for female participants;
- Agree to one of the following methods of birth control (if female), unless she or partner are surgically sterile: oral contraceptives, Contraceptive sponge, patch, double barrier, intrauterine contraceptive device, etonogestrel implant, medroxyprogesterone acetate contraceptive injection, hormonal vaginal contraceptive ring, complete abstinence from sexual intercourse.
Who cannot join
- Have current (last 12 months) DSM-5 diagnosis of substance use disorder for any psychoactive substances other than nicotine;
- Have a lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any other psychotic disorder;
- Have a score of 3 or greater on the Columbia Suicide Severity Rating Scale (C-SSRS) at screening or anytime during study participation;
- Have a positive urine screen for any substances, including cannabis
- Have a breathalyzer reading above 0.000 g/dl;
- Be pregnant, nursing, or planning to become pregnant while taking part in the study;
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- Have a medical condition that may interfere with safe study participation;
- Have clinically significant abnormalities on the EKG;
- Have evidence of renal impairment, defined by an eGFR value of <90 ml/min;
- Have evidence of hepatic impairment, defined by a score of ≥5 points on the Child-Pugh assessment of liver function;
- Exceed Grade 2 laboratory or vital sign abnormalities, based on FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials";
- Have past month use of cannabis or cannabis products;
- Have past month use of electronic nicotine delivery system (ENDS);
- Have use of any medications (other than methods of birth control as listed in inclusion criteria for female participants) within 14 days or 5 half-lives (whichever is longer) prior to study drug administration, and throughout the study, including medication for smoking cessation, any prescription, OTC, dietary supplements, herbal products, or vitamins;
- Have any other circumstances that, in the opinion of the investigators, would not be a good fit for study participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Development of Tetrahydrocannabivarin as a Treatment for Smokers
This study will randomize 32 non-treatment-seeking individuals who smoke cigarettes daily into a randomized, crossover, double-blind, placebo-controlled study testing the safety, tolerability, and initial efficacy of Δ9-tetrahydrocannabivarin (Δ9-THCV).
Read the detailed description
The objective of this study is to examine the safety, tolerability, and initial efficacy of Δ9-tetrahydrocannabivarin (Δ9-THCV) in daily smokers. We will randomize 32 non-treatment-seeking adults who smoke cigarettes daily (50% female) into a randomized, double-blind, placebo-controlled, counter-balanced, within-subject human laboratory study of Δ9-THCV (10 mg oral) and matched placebo. Specifically, participants will complete two 5-day outpatient medication periods, with a 14-day washout period in between, during which they will receive either Δ9-THCV or placebo in a counter-balanced order, such that all participants will complete both medication conditions across the study. Following each 5-day medication period, participants will complete a laboratory study visit during which they will undergo the McKee Smoking Lapse Task to assess the ability to resist smoking, cigarette self-administration, craving, withdrawal, and subjective effects of nicotine. Total study participation will be approximately 4 weeks.
- Conditions
- Tobacco Use Disorder, Smoking Cessation
- Being tested
- Δ9-Tetrahydrocannabivarin (oral gummy), Matched Placebo (oral gummy)
- Keywords
- smoking cessation, tobacco use disorder, cigarette smoking, THCV, Tetrahydrocannabivarin
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Δ9-Tetrahydrocannabivarin (oral gummy)Drug
10mg Δ9-Tetrahydrocannabivarin oral gummy
Matched Placebo (oral gummy)Drug
Matched Placebo (oral gummy, 0mg Δ9-Tetrahydrocannabivarin)
| Study group | Role | What they receive |
|---|---|---|
| Δ9-THCV first, then placebo. | Experimental | Participants will first take a 10mg Δ9-THCV gummy once a day for 5 days. After a 14-day washout period, participants will take a matched placebo gummy (0mg Δ9-THCV) once a day for 5 days. Receives: Drug: Δ9-Tetrahydrocannabivarin (oral gummy); Drug: Matched Placebo (oral gummy) |
| Placebo first, then THCV | Experimental | Participants will take a placebo gummy (0mg Δ9-THCV) once a day for 5 days. After a 14-day washout period, participants will take a 10mg Δ9-THCV gummy once a day for 5 days. Receives: Drug: Δ9-Tetrahydrocannabivarin (oral gummy); Drug: Matched Placebo (oral gummy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency to initiate smoking
Participants will complete the McKee Smoking Lapse Task following overnight abstinence to assess the effects of oral Δ9-THCV (10 mg), compared with placebo, on the ability to resist smoking. The primary outcome is latency to initiate smoking during the 50-minute delay period, defined as the number of minutes participants delay smoking their first cigarette (range: 0-50 minutes).
Measured: Assessed during each 5-day medication condition, following overnight abstinence on Day 5
Number of cigarettes smoked during self-administration
Participants will complete the McKee Smoking Lapse Task following overnight abstinence to assess the effects of oral Δ9-THCV (10 mg), compared with placebo, on cigarette self-administration. The outcome is the number of cigarettes smoked during the 60-minute self-administration period of the task (no set range).
Measured: Assessed during each 5-day medication condition, following overnight abstinence on Day 5
Secondary outcomes (7)
Questionnaire of Smoking Urges-Brief total score
Participants will complete the 10-item Questionnaire of Smoking Urges-Brief (QSU-Brief) during the McKee Smoking Lapse Task to assess cigarette craving. The QSU-Brief assesses urges and cravings using a 7-point Likert response scale, with higher scores indicating greater craving (range: 10-70). Cue-induced cigarette craving in response to cigarette (vs. neutral) cues will be calculated and compared between the Δ9-THCV and placebo conditions.
Measured: Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence
Minnesota Nicotine Withdrawal Scale score
Participants will complete ratings of nicotine withdrawal following overnight abstinence using the 8-item Minnesota Nicotine Withdrawal Scale (MNWS), with higher values indicating more severe withdrawal (range: 0-32). Differences in MNWS scores will be evaluated between the Δ9-THCV and placebo conditions.
Measured: Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence
Modified Cigarette Evaluation Questionnaire satisfaction score
Participants will complete the 12-item Modified Cigarette Evaluation Questionnaire (mCEQ) during the cigarette self-administration period of the McKee Smoking Lapse Task to assess satisfaction associated with smoking. Items are rated on a 7-point scale, with higher scores indicating greater endorsement. The satisfaction subscale score is calculated as the sum of Items 1, 2, and 12 (range: 3-21). Differences in satisfaction scores will be evaluated between the Δ9-THCV and placebo conditions.
Measured: Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence.
Modified Cigarette Evaluation Questionnaire psychological reward score
Participants will complete the 12-item Modified Cigarette Evaluation Questionnaire (mCEQ) during the cigarette self-administration period of the McKee Smoking Lapse Task to assess psychological reward associated with smoking. Items are rated on a 7-point scale, with higher scores indicating greater endorsement. The psychological reward subscale score is calculated as the sum of Items 4, 5, 6, 7, 8 (range: 5-35). Differences in psychological reward scores will be evaluated between the Δ9-THCV and placebo conditions.
Measured: Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence.
Modified Cigarette Evaluation Questionnaire nausea/dizziness score
Participants will complete the 12-item Modified Cigarette Evaluation Questionnaire (mCEQ) during the cigarette self-administration period of the McKee Smoking Lapse Task to assess nausea and dizziness associated with smoking. Items are rated on a 7-point scale, with higher scores indicating greater endorsement. The nausea/dizziness subscale score is calculated as the sum of Items 9 and 10 (range: 2-14). Differences in nausea/dizziness scores will be evaluated between the Δ9-THCV and placebo conditions.
Measured: Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence.
Modified Cigarette Evaluation Questionnaire craving relief score
Participants will complete the 12-item Modified Cigarette Evaluation Questionnaire (mCEQ) during the cigarette self-administration period of the McKee Smoking Lapse Task to assess craving relief associated with smoking. Items are rated on a 7-point scale, with higher scores indicating greater endorsement. The craving relief subscale score is based on Item 11 (range: 1-7). Differences in craving relief scores will be evaluated between the Δ9-THCV and placebo conditions.
Measured: Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence.
Modified Cigarette Evaluation Questionnaire enjoyment of airway sensations score
Participants will complete the 12-item Modified Cigarette Evaluation Questionnaire (mCEQ) during the cigarette self-administration period of the McKee Smoking Lapse Task to assess the enjoyment of airway sensations associated with smoking. Items are rated on a 7-point scale, with higher scores indicating greater endorsement. The enjoyment of airway sensations subscale score is based on Item 3 (range: 1-7). Differences in enjoyment of airway sensations scores will be evaluated between the Δ9-THCV and placebo conditions.
Measured: Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study startOct 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
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 University of California, Los AngelesThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study uses a randomized, double-blind, placebo-controlled crossover design in which participants receive both Δ9-THCV (10mg) and a matched placebo across two separate 5-day outpatient medication conditions. Treatment order will be counter-balanced across participants, and the medication conditions will be separated by a 14-day washout period.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Lara Ray, PhD, University of California, Los Angeles
- Investigators
- Lara A Ray, PhD, Principal investigator, University of California, Los AngelesErica N Grodin, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636356
- Sponsor's protocol ID
- IRB-26-1097
- Other IDs
- R21DA059769
- Status last verified
- Aug 2026
- First submitted
- 26 May 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Tetrahydrocannabivarin as a Treatment for Smokers
- ClinicalTrials.gov ID
- NCT07636356
- Acronym / sponsor ID
- IRB-26-1097
- Conditions
- Tobacco Use Disorder, Smoking Cessation
- Keywords
- smoking cessation, tobacco use disorder, cigarette smoking, THCV, Tetrahydrocannabivarin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 9 Jun 2026 (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 randomize 32 non-treatment-seeking individuals who smoke cigarettes daily into a randomized, crossover, double-blind, placebo-controlled study testing the safety, tolerability, and initial efficacy of Δ9-tetrahydrocannabivarin (Δ9-THCV).
Detailed description
The objective of this study is to examine the safety, tolerability, and initial efficacy of Δ9-tetrahydrocannabivarin (Δ9-THCV) in daily smokers. We will randomize 32 non-treatment-seeking adults who smoke cigarettes daily (50% female) into a randomized, double-blind, placebo-controlled, counter-balanced, within-subject human laboratory study of Δ9-THCV (10 mg oral) and matched placebo. Specifically, participants will complete two 5-day outpatient medication periods, with a 14-day washout period in between, during which they will receive either Δ9-THCV or placebo in a counter-balanced order, such that all participants will complete both medication conditions across the study. Following each 5-day medication period, participants will complete a laboratory study visit during which they will undergo the McKee Smoking Lapse Task to assess the ability to resist smoking, cigarette self-administration, craving, withdrawal, and subjective effects of nicotine. Total study participation will be approximately 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This study uses a randomized, double-blind, placebo-controlled crossover design in which participants receive both Δ9-THCV (10mg) and a matched placebo across two separate 5-day outpatient medication conditions. Treatment order will be counter-balanced across participants, and the medication conditions will be separated by a 14-day washout period.
| Arm | Type | Receives |
|---|---|---|
| Δ9-THCV first, then placebo. | Experimental | Drug: Δ9-Tetrahydrocannabivarin (oral gummy), Drug: Matched Placebo (oral gummy)Participants will first take a 10mg Δ9-THCV gummy once a day for 5 days. After a 14-day washout period, participants will take a matched placebo gummy (0mg Δ9-THCV) once a day for 5 days. |
| Placebo first, then THCV | Experimental | Drug: Δ9-Tetrahydrocannabivarin (oral gummy), Drug: Matched Placebo (oral gummy)Participants will take a placebo gummy (0mg Δ9-THCV) once a day for 5 days. After a 14-day washout period, participants will take a 10mg Δ9-THCV gummy once a day for 5 days. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be between the ages of 21 and 65;
- Smoke 10 or more combustible cigarettes per day;
- Have fewer than 3 months of smoking abstinence in the past year;
- Has self-reported ≥10 lifetime uses of cannabis products;
- Have self-reported recent (past 3-month) use of cannabis products;
Key exclusion criteria (15 listed)
- Have current (last 12 months) DSM-5 diagnosis of substance use disorder for any psychoactive substances other than nicotine;
- Have a lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any other psychotic disorder;
- Have a score of 3 or greater on the Columbia Suicide Severity Rating Scale (C-SSRS) at screening or anytime during study participation;
- Have a positive urine screen for any substances, including cannabis
- Have a breathalyzer reading above 0.000 g/dl;
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 |
|---|---|---|
| Δ9-Tetrahydrocannabivarin (oral gummy)10mg Δ9-Tetrahydrocannabivarin oral gummy | Drug | Placebo first, then THCV, Δ9-THCV first, then placebo. |
| Matched Placebo (oral gummy)Matched Placebo (oral gummy, 0mg Δ9-Tetrahydrocannabivarin) | Drug | Placebo first, then THCV, Δ9-THCV first, then placebo. |
Primary outcome
Latency to initiate smoking
Time frame: Assessed during each 5-day medication condition, following overnight abstinence on Day 5
Participants will complete the McKee Smoking Lapse Task following overnight abstinence to assess the effects of oral Δ9-THCV (10 mg), compared with placebo, on the ability to resist smoking. The primary outcome is latency to initiate smoking during the 50-minute delay period, defined as the number of minutes participants delay smoking their first cigarette (range: 0-50 minutes).
Number of cigarettes smoked during self-administration
Time frame: Assessed during each 5-day medication condition, following overnight abstinence on Day 5
Participants will complete the McKee Smoking Lapse Task following overnight abstinence to assess the effects of oral Δ9-THCV (10 mg), compared with placebo, on cigarette self-administration. The outcome is the number of cigarettes smoked during the 60-minute self-administration period of the task (no set range).
7 secondary outcomes
Questionnaire of Smoking Urges-Brief total score
Time frame: Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence
Minnesota Nicotine Withdrawal Scale score
Time frame: Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence
Modified Cigarette Evaluation Questionnaire satisfaction score
Time frame: Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence.
Modified Cigarette Evaluation Questionnaire psychological reward score
Time frame: Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence.
Modified Cigarette Evaluation Questionnaire nausea/dizziness score
Time frame: Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence.
Modified Cigarette Evaluation Questionnaire craving relief score
Time frame: Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence.
Modified Cigarette Evaluation Questionnaire enjoyment of airway sensations score
Time frame: Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- 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.
Lara A Ray, PhD principal investigator
University of California, Los Angeles
Erica N Grodin, PhD principal investigator
University of California, Los Angeles
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Δ9-Tetrahydrocannabivarin (oral gummy) in people with Tobacco Use Disorder and Smoking Cessation, run by University of California, Los Angeles.
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 8 inclusion and 15 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: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Jenkins, MS (310-206-6756, jenkinsj@ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Latency to initiate smoking (time frame: Assessed during each 5-day medication condition, following overnight abstinence on Day 5). The study lists 2 primary outcomes in all. 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 4 Aug 2026.