Cannabis Use DisorderPhase 2NCT06569394
A Study of Cannabidiol in Young Adult Cannabis Users
A Phase 2 study testing Broad Spectrum Cannabidiol (bsCBD) 400 mg in people with Cannabis Use Disorder, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The investigators will study the harm-reducing effect of hemp-derived CBD in non-treatment-seeking emerging adults who use cannabis regularly. The study will use a novel naturalistic cannabis administration approach, which examines ecologically valid cannabis use utilizing a mobile lab setting to assess the effects of… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Cannabis Use Disorder
- What is being tested?
- Broad Spectrum Cannabidiol (bsCBD) 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2024to 30 Jun 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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ages 18-25
- Must have used cannabis flower or concentrates at least five days per week for the past year.
- Currently not seeking to cut down or stop cannabis use
- At least two symptoms of a DSM-5 cannabis use disorder
Who cannot join
- Use of any illicit substance besides alcohol, nicotine, or cannabis (e.g., cocaine, opiates, methamphetamine, MDMA, benzodiazepines, or barbiturates) in the past 60 days, as indicated by self-report and urine toxicology screening at the beginning of each study visit.
- Alcohol use on 3 or more days per week, and/or >3 drinks per drinking day in the past 60 days. Participants must also have a breath alcohol level of 0 at the beginning of each study visit.
- Daily nicotine use.
- Meets DSM-5 diagnostic criteria for a psychotic disorder (e.g., schizophrenia, schizophreniform disorder, schizoaffective disorder), bipolar disorder, major depression with suicidal ideation, or a history of treatment for these disorders.
- Current cardiovascular or respiratory disease (e.g., coronary artery disease, severe asthma, chronic obstructive pulmonary disease)
- Current use of any psychotropic (e.g., antidepressants, anxiogenics) or hepatotoxic medication.
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- Current use of anti-epileptic medications (e.g., clobazam, sodium valproate) or medications known to have major interactions with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, and/or teriflunomide) or a history of seizures.
- Current use of strong or moderate CYP3A4 inhibitors or inducers (commonly used examples not captured by other exclusion criteria include protease inhibitors, macrolide antibiotics [e.g., erythromycin], azole antifungals [e.g., ketoconazole], verapamil, and grapefruit juice).
- Current use of strong or moderate CYP2C19 inhibitors or inducers (commonly used examples not captured by other exclusion criteria include proton pump inhibitors, prednisone, and norethisterone).
- Current or past hepatocellular disease, as indicated by medical history or alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin greater than two times the upper limit of the normal range at screening.
- For female participants, pregnancy or trying to become pregnant. A positive pregnancy test at the beginning of any study visit will result in exclusion from ongoing study participation.
- For female participants, currently lactating.
- For female patients of childbearing potential, not willing to use at least one approved method of birth control while taking the study medication, unless she is surgically sterile, partner is surgically sterile, or she is postmenopausal (one year).
- Current suicidality risk as indicated during the conduct of the C-SSRS with concurrence after a study physician's or PI evaluation if the response to C-SSRS questions 1 or 2 is "yes"
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Christian J Hopfer, MD, 303-724-3170, christian.hopfer@cuanschutz.edu
Kristen M Raymond, BA, 303-724-3196, kristen.raymond@cuanschutz.edu
About this study
Official title: A Randomized, Placebo Controlled Study of Cannabidiol in Young Adult Cannabis Users
The investigators will study the harm-reducing effect of hemp-derived CBD in non-treatment-seeking emerging adults who use cannabis regularly. The study will use a novel naturalistic cannabis administration approach, which examines ecologically valid cannabis use utilizing a mobile lab setting to assess the effects of the cannabis products the participants regularly use. The investigators will recruit a sample of emerging adults, half of whom primarily use flower products and half of whom primarily use concentrate products. Individuals will be randomly assigned to hemp-derived CBD or placebo.
Read the detailed description
Emerging adults have the highest prevalence of cannabis use and CUD of any age group. Despite high rates of use and CUD, treatment seeking is relatively uncommon among emerging adults. Those who use cannabis are less confident in their ability to abstain and show higher rates of ambivalence regarding the goal of abstinence than those who use other drugs. Thus, emerging adult cannabis users may be more receptive to non-abstinence or harm reduction approaches. The overarching aim of this proposal is to assess the effects of hemp-derived CBD in emerging adults on harms associated with cannabis use including subjective intoxication, affect and mood, psychotic experiences, and cognitive functioning, as well as to examine whether CBD supplementation reduces self-administration of THC and symptoms of CUD. The investigators propose a study design with high external validity and experimental controls to study the harm-reducing effect of hemp-derived CBD in non-treatment-seeking emerging adults who use cannabis regularly. The study will use a novel naturalistic cannabis administration approach, which examines ecologically valid cannabis use utilizing a mobile lab setting to assess the effects of the cannabis products the participants regularly use. The investigators will recruit a sample of emerging adults, half of whom primarily use flower products and half of whom primarily use concentrate products. Individuals will be randomly assigned to hemp-derived CBD or placebo, consistent with the preliminary studies that have approved US Food and Drug Administration (FDA) Investigation New Drug (IND 153535 and 157515).
The specific aims are to:
Aim 1: Test whether assignment to hemp-derived CBD, relative to placebo, over 8 weeks is associated with a) reduced self-administration of THC, b) a reduction in CUD symptoms, c) lower levels of anxiety, depression, d) better cognitive function, and e) higher anandamide (AEA) levels. Hypothesis: Compared to baseline, the CBD group will demonstrate reduced THC administration, fewer CUD symptoms, lower levels of anxiety and depression, and better cognitive functioning at 4 and 8 weeks compared to the placebo group. At 12 weeks (4 weeks post-trial), these effects will persist. Assignment to CBD will be correlated with higher AEA levels.
Aim 2: Test whether assignment to hemp-derived CBD, relative to placebo, reduces acute effects of cannabis administration on: a) subjective drug effects, b) cognitive function, and c) mood and psychotic symptoms. Hypothesis: Compared to cannabis self-administration at baseline (without CBD), the CBD group will demonstrate lower subjective drug effects (mood elevation, anxiety), fewer psychotic symptoms, and better cognitive functioning after cannabis self-administration at 4 and 8 weeks compared to the placebo group. At 12 weeks (4 weeks post-trial), these effects will persist.
Aim 3: Test whether cannabis product type (flower vs. concentrates) moderates the association between CBD assignment and a) cannabis use, b) mood and anxiety, and c) cognitive functioning in both longer-term (aim 1) and acute (aim 2) effects. Hypothesis: CBD effects will be greater among those who use concentrates compared to those who use flower products for both longer-term and acute effects.
- Conditions
- Cannabis Use Disorder
- Being tested
- Broad Spectrum Cannabidiol (bsCBD) 400 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broad Spectrum Cannabidiol (bsCBD) 400 mgDrug
Participants in this Arm will take 400 mg of bsCBD daily. Participants will take medication by mouth with food in the morning and evening.
PlaceboDrug
Participants in this Arm will take a medically inert placebo. Participants will take medication by mouth with food in the morning and evening.
| Study group | Role | What they receive |
|---|---|---|
| Broad Spectrum Cannabidiol (bsCBD) 400 mg | Active comparator | bsCBD in a 400 mg dose will be used as described in the study arms. Receives: Drug: Broad Spectrum Cannabidiol (bsCBD) 400 mg |
| Placebo | Placebo comparator | A medically inert placebo medication will be used as described in the study arms. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in blood THC-COOH levels
THC-COOH levels in blood samples collected at baseline, Week 4, and Week 8 of medication ingestion.
Measured: 8 weeks
Difference in blood THC levels
THC levels in blood samples collected before and after cannabis use at baseline, Week 4, and Week 8 of medication ingestion.
Measured: 1 hour pre and post THC self-administration at baseline, 4 weeks, and 8 weeks
Difference in cannabis use
Total number of days of cannabis use during the 8-week medication period as reported on daily diaries.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start9 Dec 2024
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis Use DisorderStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind placebo controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Christian J Hopfer, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569394
- Sponsor's protocol ID
- 23-0954
- Other IDs
- 1P50DA056408
- Status last verified
- Apr 2026
- First submitted
- 22 Aug 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared through a NIDA P50 data sharing resource.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled Study of Cannabidiol in Young Adult Cannabis Users
- ClinicalTrials.gov ID
- NCT06569394
- Acronym / sponsor ID
- 23-0954
- Conditions
- Cannabis Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 26 Aug 2024 (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.
The investigators will study the harm-reducing effect of hemp-derived CBD in non-treatment-seeking emerging adults who use cannabis regularly. The study will use a novel naturalistic cannabis administration approach, which examines ecologically valid cannabis use utilizing a mobile lab setting to assess the effects of the cannabis products the participants regularly use. The investigators will recruit a sample of emerging adults, half of whom primarily use flower products and half of whom primarily use concentrate products. Individuals will be randomly assigned to hemp-derived CBD or placebo.
Detailed description
Emerging adults have the highest prevalence of cannabis use and CUD of any age group. Despite high rates of use and CUD, treatment seeking is relatively uncommon among emerging adults. Those who use cannabis are less confident in their ability to abstain and show higher rates of ambivalence regarding the goal of abstinence than those who use other drugs. Thus, emerging adult cannabis users may be more receptive to non-abstinence or harm reduction approaches. The overarching aim of this proposal is to assess the effects of hemp-derived CBD in emerging adults on harms associated with cannabis use including subjective intoxication, affect and mood, psychotic experiences, and cognitive functioning, as well as to examine whether CBD supplementation reduces self-administration of THC and symptoms of CUD. The investigators propose a study design with high external validity and experimental controls to study the harm-reducing effect of hemp-derived CBD in non-treatment-seeking emerging adults who use cannabis regularly. The study will use a novel naturalistic cannabis administration approach, which examines ecologically valid cannabis use utilizing a mobile lab setting to assess the effects of the cannabis products the participants regularly use. The investigators will recruit a sample of emerging adults, half of whom primarily use flower products and half of whom primarily use concentrate products. Individuals will be randomly assigned to hemp-derived CBD or placebo, consistent with the preliminary studies that have approved US Food and Drug Administration (FDA) Investigation New Drug (IND 153535 and 157515).
The specific aims are to:
Aim 1: Test whether assignment to hemp-derived CBD, relative to placebo, over 8 weeks is associated with a) reduced self-administration of THC, b) a reduction in CUD symptoms, c) lower levels of anxiety, depression, d) better cognitive function, and e) higher anandamide (AEA) levels. Hypothesis: Compared to baseline, the CBD group will demonstrate reduced THC administration, fewer CUD symptoms, lower levels of anxiety and depression, and better cognitive functioning at 4 and 8 weeks compared to the placebo group. At 12 weeks (4 weeks post-trial), these effects will persist. Assignment to CBD will be correlated with higher AEA levels.
Aim 2: Test whether assignment to hemp-derived CBD, relative to placebo, reduces acute effects of cannabis administration on: a) subjective drug effects, b) cognitive function, and c) mood and psychotic symptoms. Hypothesis: Compared to cannabis self-administration at baseline (without CBD), the CBD group will demonstrate lower subjective drug effects (mood elevation, anxiety), fewer psychotic symptoms, and better cognitive functioning after cannabis self-administration at 4 and 8 weeks compared to the placebo group. At 12 weeks (4 weeks post-trial), these effects will persist.
Aim 3: Test whether cannabis product type (flower vs. concentrates) moderates the association between CBD assignment and a) cannabis use, b) mood and anxiety, and c) cognitive functioning in both longer-term (aim 1) and acute (aim 2) effects. Hypothesis: CBD effects will be greater among those who use concentrates compared to those who use flower products for both longer-term and acute effects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind placebo controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Broad Spectrum Cannabidiol (bsCBD) 400 mg | Active comparator | Drug: Broad Spectrum Cannabidiol (bsCBD) 400 mgbsCBD in a 400 mg dose will be used as described in the study arms. |
| Placebo | Placebo comparator | Drug: PlaceboA medically inert placebo medication will be used as described in the study arms. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ages 18-25
- Must have used cannabis flower or concentrates at least five days per week for the past year.
- Currently not seeking to cut down or stop cannabis use
- At least two symptoms of a DSM-5 cannabis use disorder
Key exclusion criteria (14 listed)
- Use of any illicit substance besides alcohol, nicotine, or cannabis (e.g., cocaine, opiates, methamphetamine, MDMA, benzodiazepines, or barbiturates) in the past 60 days, as indicated by self-report and urine toxicology screening at the beginning of each study visit.
- Alcohol use on 3 or more days per week, and/or >3 drinks per drinking day in the past 60 days. Participants must also have a breath alcohol level of 0 at the beginning of each study visit.
- Daily nicotine use.
- Meets DSM-5 diagnostic criteria for a psychotic disorder (e.g., schizophrenia, schizophreniform disorder, schizoaffective disorder), bipolar disorder, major depression with suicidal ideation, or a history of treatment for these disorders.
- Current cardiovascular or respiratory disease (e.g., coronary artery disease, severe asthma, chronic obstructive pulmonary disease)
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 |
|---|---|---|
| Broad Spectrum Cannabidiol (bsCBD) 400 mgParticipants in this Arm will take 400 mg of bsCBD daily. Participants will take medication by mouth with food in the morning and evening. | Drug | Broad Spectrum Cannabidiol (bsCBD) 400 mg |
| PlaceboParticipants in this Arm will take a medically inert placebo. Participants will take medication by mouth with food in the morning and evening. | Drug | Placebo |
Primary outcome
Difference in blood THC-COOH levels
Time frame: 8 weeks
THC-COOH levels in blood samples collected at baseline, Week 4, and Week 8 of medication ingestion.
Difference in blood THC levels
Time frame: 1 hour pre and post THC self-administration at baseline, 4 weeks, and 8 weeks
THC levels in blood samples collected before and after cannabis use at baseline, Week 4, and Week 8 of medication ingestion.
Difference in cannabis use
Time frame: 8 Weeks
Total number of days of cannabis use during the 8-week medication period as reported on daily diaries.
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 1 May 2026.
- Individual participant dataSharing planned: No. Data will be shared through a NIDA P50 data sharing resource.
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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.
Christian J Hopfer, MD principal investigator
University of Colorado, Denver
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 Broad Spectrum Cannabidiol (bsCBD) 400 mg in people with Cannabis Use Disorder, run by University of Colorado, Denver 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 14 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: looking for participants now, as of the sponsor's last update on 1 May 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. Some participants in this study may receive a placebo. 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 Christian J Hopfer, MD (303-724-3170, christian.hopfer@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in blood THC-COOH levels (time frame: 8 weeks). The study lists 3 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 1 May 2026.