Cannabis Use DisorderPhase 2NCT06575751
Cannabidiol and Cannabis Concentrate Users
A Phase 2 study testing Broad Spectrum Cannabidiol (bsCBD) 400 mg and Broad Spectrum Cannabidiol (bsCBD) 200 mg in people with Cannabis Use Disorder, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study is a randomized, placebo-controlled, dose-ranging trial of plant-derived cannabidiol (CBD) among people who regularly use cannabis concentrates but are not trying to stop or cut down on their use. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Cannabis Use Disorder
- What is being tested?
- Broad Spectrum Cannabidiol (bsCBD) 400 mg and Broad Spectrum Cannabidiol (bsCBD) 200 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 4 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 25-60.
- Regular use (at least 4 times per week) of cannabis concentrates for the last year.
- Not currently seeking to cut down or stop cannabis use.
- At least one episode of 3 consecutive days of cannabis abstinence with no experience of severe withdrawal symptoms (i.e., >=4 DSM-5 Cannabis Withdrawal symptoms rated as "severe"), in the last 90 days.
- 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.
- Use of CBD-containing products other than cannabis concentrates in the past 90 days.
- 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, or major depression with suicidal ideation, or has a history of treatment for these disorders.
- Current cardiovascular or respiratory disease (e.g., coronary artery disease, severe asthma, chronic obstructive pulmonary disease, etc.)
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- Current use of any psychotropic (e.g., antidepressants, anxiogenics) or hepatotoxic medications.
- Currently 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) or aspartate aminotransferase (AST) > 2 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 an 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
Joseph P Schacht, PhD, 303-724-3773, joseph.schacht@cuanschutz.edu
Kristen M Raymond, BA, 303-724-3196, kristen.raymond@cuanschutz.edu
About this study
Official title: Cannabidiol and Cannabis Concentrate Users: A Randomized, Placebo Controlled Study
This study is a randomized, placebo-controlled, dose-ranging trial of plant-derived cannabidiol (CBD) among people who regularly use cannabis concentrates but are not trying to stop or cut down on their use. The main questions it aims to answer are whether CBD, relative to placebo, reduces cannabis concentrate use, the subjective effects of cannabis, or cannabis craving. Participants will take CBD (200 mg or 400 mg per day) or placebo for 4 weeks and will complete three visits during the study medication period, all conducted using a mobile laboratory.
Read the detailed description
The overarching aim of this proposal is to combine a naturalistic cannabis administration paradigm with a placebo-controlled, dose-ranging randomized controlled trial of plant-derived cannabidiol (CBD) to evaluate CBD effects on cannabis concentrate use, subjective effects, and cannabis cue reactivity. To achieve this aim, 120 adult frequent concentrate users will be recruited to complete a four-week protocol during which they will complete three sessions in a mobile pharmacology laboratory. Up to 200 participants may be consented/enrolled to account for screen failures and attrition. In two of the sessions, participants will use their typical cannabis concentrate on an ad libitum basis. Amount of delta-9-tetrahydrocannabinol (THC) self-administration during these sessions will be quantified by THC blood levels, obtained in the mobile lab immediately before and after use. Subjective drug effects and exogenous and endogenous cannabinoid biomarkers will also be quantified before and after THC use. Immediately after the first mobile lab session, participants will be randomly assigned to take either 200 mg or 400 mg of plant-derived, broad-spectrum CBD or matched placebo (40 participants per group) daily for four weeks. Participants will complete a second mobile lab session after two weeks to provide a blood sample that will be analyzed for cannabinoid levels. At this session, participants will also complete a cannabis cue reactivity paradigm. Participants will complete a second mobile lab session after four weeks of study medication ingestion, during which blood draws and THC self-administration will be repeated.
There are three aims:
Aim 1. Test the effect of CBD, relative to placebo and to baseline, on cannabis use over four weeks and THC self-administration in the mobile laboratory.
Hypothesis 1a. Both doses of CBD, relative to placebo, will reduce THC metabolite levels at weeks 2 and 4.
Hypothesis 1b. Both doses of CBD, relative to placebo and to baseline, will reduce the amount of THC that participants choose to consume in the mobile laboratory, as assessed by pre- vs. post-use THC blood levels.
Aim 2. Test the effect of CBD, relative to placebo and to baseline, on subjective drug effects (intoxication, psychotomimetic symptoms, anxiety, and negative affect) following acute cannabis concentrate use.
Hypothesis 2. Both doses of CBD, relative to placebo and to baseline, will reduce intoxication, paranoia, anxiety, and negative affect following acute use, even after controlling for between-group differences in amount of concentrate used.
Aim 3. Test the effect of CBD, relative to placebo, on cannabis cue-elicited craving and evaluate whether this effect mediates CBD effects on cannabis use.
Hypothesis 3a. Both doses of CBD, relative to placebo, will reduce cannabis craving.
Hypothesis 3b. CBD's effect on craving at week 2 will mediate its effect on THC metabolite levels at week 4.
For all aims, a linear effect of CBD dose is hypothesized, with the greatest effects in the 400 mg CBD group. Successful achievement of these aims will allow determination of an efficacious dose of CBD that reduces high-THC cannabis use, subjective drug effects, and craving, setting the stage for a subsequent RCT of plant-derived CBD to treat these outcomes in treatment-seeking high-THC cannabis concentrate users.
- Conditions
- Cannabis Use Disorder
- Being tested
- Broad Spectrum Cannabidiol (bsCBD) 400 mg, Broad Spectrum Cannabidiol (bsCBD) 200 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.
Broad Spectrum Cannabidiol (bsCBD) 200 mgDrug
Participants in this Arm will take 200 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 |
| Broad Spectrum Cannabidiol (bsCBD) 200 mg | Active comparator | bsCBD in a 200 mg dose will be used as described in the study arms. Receives: Drug: Broad Spectrum Cannabidiol (bsCBD) 200 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 11-Nor-9-carboxy-THC (THC-COOH) levels
THC-COOH levels in blood samples collected at baseline, Week 2, and Week 4 of medication ingestion
Measured: 4 weeks
Difference in blood delta-9-tetrahydrocannabinol (THC) levels
THC levels in blood samples collected before and after cannabis use at baseline and at Week 4 of medication ingestion
Measured: 4 weeks
Difference in cannabis use
Total number of days of cannabis use during the 4-week medication period as reported on daily diaries
Measured: 4 weeks
Secondary outcomes (5)
Difference in cannabis-induced intoxication
Drug Effects Questionnaire score following cannabis use at baseline and at Week 4 of medication ingestion (minimum = 0, maximum = 5, higher scores = greater intoxication)
Measured: 4 weeks
Difference in cannabis-induced subjective effects
Addiction Research Center Inventory Marijuana score following cannabis use at baseline and at Week 4 of medication ingestion (minimum = 0, maximum = 12, higher scores = greater subjective effects)
Measured: 4 weeks
Difference in cannabis-induced psychotomimetic symptoms
Psychotomimetic States Inventory paranoia and cognitive disorganization item scores following cannabis use at baseline and at Week 4 of medication ingestion (minimum = 0, maximum = 54, higher scores = greater psychotomimetic symptoms)
Measured: 4 weeks
Difference in cannabis-induced anxiety and negative affect
Profile of Mood States short form tension, vigor, and elation subscale item scores following cannabis use at baseline and at Week 4 of medication ingestion (minimum = 0, maximum = 60, higher scores = greater anxiety and negative affect)
Measured: 4 weeks
Difference in cannabis craving
Marijuana Craving Questionnaire-Short Form score before and after the cannabis cue reactivity procedure at Week 2 of medication ingestion (minimum = 12, maximum = 84, higher scores = greater craving)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start4 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
- 120 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
- Joseph P Schacht, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575751
- Sponsor's protocol ID
- 23-0953
- 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
- Cannabidiol and Cannabis Concentrate Users: A Randomized, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT06575751
- Acronym / sponsor ID
- 23-0953
- Conditions
- Cannabis Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 28 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.
This study is a randomized, placebo-controlled, dose-ranging trial of plant-derived cannabidiol (CBD) among people who regularly use cannabis concentrates but are not trying to stop or cut down on their use. The main questions it aims to answer are whether CBD, relative to placebo, reduces cannabis concentrate use, the subjective effects of cannabis, or cannabis craving. Participants will take CBD (200 mg or 400 mg per day) or placebo for 4 weeks and will complete three visits during the study medication period, all conducted using a mobile laboratory.
Detailed description
The overarching aim of this proposal is to combine a naturalistic cannabis administration paradigm with a placebo-controlled, dose-ranging randomized controlled trial of plant-derived cannabidiol (CBD) to evaluate CBD effects on cannabis concentrate use, subjective effects, and cannabis cue reactivity. To achieve this aim, 120 adult frequent concentrate users will be recruited to complete a four-week protocol during which they will complete three sessions in a mobile pharmacology laboratory. Up to 200 participants may be consented/enrolled to account for screen failures and attrition. In two of the sessions, participants will use their typical cannabis concentrate on an ad libitum basis. Amount of delta-9-tetrahydrocannabinol (THC) self-administration during these sessions will be quantified by THC blood levels, obtained in the mobile lab immediately before and after use. Subjective drug effects and exogenous and endogenous cannabinoid biomarkers will also be quantified before and after THC use. Immediately after the first mobile lab session, participants will be randomly assigned to take either 200 mg or 400 mg of plant-derived, broad-spectrum CBD or matched placebo (40 participants per group) daily for four weeks. Participants will complete a second mobile lab session after two weeks to provide a blood sample that will be analyzed for cannabinoid levels. At this session, participants will also complete a cannabis cue reactivity paradigm. Participants will complete a second mobile lab session after four weeks of study medication ingestion, during which blood draws and THC self-administration will be repeated.
There are three aims:
Aim 1. Test the effect of CBD, relative to placebo and to baseline, on cannabis use over four weeks and THC self-administration in the mobile laboratory.
Hypothesis 1a. Both doses of CBD, relative to placebo, will reduce THC metabolite levels at weeks 2 and 4.
Hypothesis 1b. Both doses of CBD, relative to placebo and to baseline, will reduce the amount of THC that participants choose to consume in the mobile laboratory, as assessed by pre- vs. post-use THC blood levels.
Aim 2. Test the effect of CBD, relative to placebo and to baseline, on subjective drug effects (intoxication, psychotomimetic symptoms, anxiety, and negative affect) following acute cannabis concentrate use.
Hypothesis 2. Both doses of CBD, relative to placebo and to baseline, will reduce intoxication, paranoia, anxiety, and negative affect following acute use, even after controlling for between-group differences in amount of concentrate used.
Aim 3. Test the effect of CBD, relative to placebo, on cannabis cue-elicited craving and evaluate whether this effect mediates CBD effects on cannabis use.
Hypothesis 3a. Both doses of CBD, relative to placebo, will reduce cannabis craving.
Hypothesis 3b. CBD's effect on craving at week 2 will mediate its effect on THC metabolite levels at week 4.
For all aims, a linear effect of CBD dose is hypothesized, with the greatest effects in the 400 mg CBD group. Successful achievement of these aims will allow determination of an efficacious dose of CBD that reduces high-THC cannabis use, subjective drug effects, and craving, setting the stage for a subsequent RCT of plant-derived CBD to treat these outcomes in treatment-seeking high-THC cannabis concentrate users.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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. |
| Broad Spectrum Cannabidiol (bsCBD) 200 mg | Active comparator | Drug: Broad Spectrum Cannabidiol (bsCBD) 200 mgbsCBD in a 200 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
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 25-60.
- Regular use (at least 4 times per week) of cannabis concentrates for the last year.
- Not currently seeking to cut down or stop cannabis use.
- At least one episode of 3 consecutive days of cannabis abstinence with no experience of severe withdrawal symptoms (i.e., >=4 DSM-5 Cannabis Withdrawal symptoms rated as "severe"), in the last 90 days.
- At least two symptoms of a DSM-5 cannabis use disorder.
Key exclusion criteria (15 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.
- Use of CBD-containing products other than cannabis concentrates in the past 90 days.
- 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, or major depression with suicidal ideation, or has a history of treatment for these disorders.
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 |
| Broad Spectrum Cannabidiol (bsCBD) 200 mgParticipants in this Arm will take 200 mg of bsCBD daily. Participants will take medication by mouth with food in the morning and evening. | Drug | Broad Spectrum Cannabidiol (bsCBD) 200 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 11-Nor-9-carboxy-THC (THC-COOH) levels
Time frame: 4 weeks
THC-COOH levels in blood samples collected at baseline, Week 2, and Week 4 of medication ingestion
Difference in blood delta-9-tetrahydrocannabinol (THC) levels
Time frame: 4 weeks
THC levels in blood samples collected before and after cannabis use at baseline and at Week 4 of medication ingestion
Difference in cannabis use
Time frame: 4 weeks
Total number of days of cannabis use during the 4-week medication period as reported on daily diaries
5 secondary outcomes
Difference in cannabis-induced intoxication
Time frame: 4 weeks
Difference in cannabis-induced subjective effects
Time frame: 4 weeks
Difference in cannabis-induced psychotomimetic symptoms
Time frame: 4 weeks
Difference in cannabis-induced anxiety and negative affect
Time frame: 4 weeks
Difference in cannabis craving
Time frame: 2 weeks
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.
Joseph P Schacht, PhD 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 and Broad Spectrum Cannabidiol (bsCBD) 200 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 5 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: 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 Joseph P Schacht, PhD (303-724-3773, joseph.schacht@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 11-Nor-9-carboxy-THC (THC-COOH) levels (time frame: 4 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; AzTrials last refreshed its copy on 1 Nov 2026.