Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2024-12-04
2028-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Broad Spectrum Cannabidiol (bsCBD) 400 mg
bsCBD in a 400 mg dose will be used as described in the study arms.
Broad Spectrum Cannabidiol (bsCBD) 400 mg
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 mg
bsCBD in a 200 mg dose will be used as described in the study arms.
Broad Spectrum Cannabidiol (bsCBD) 200 mg
Participants in this Arm will take 200 mg of bsCBD daily. Participants will take medication by mouth with food in the morning and evening.
Placebo
A medically inert placebo medication will be used as described in the study arms.
Placebo
Participants in this Arm will take a medically inert placebo. Participants will take medication by mouth with food in the morning and evening.
Interventions
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Broad Spectrum Cannabidiol (bsCBD) 400 mg
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 mg
Participants in this Arm will take 200 mg of bsCBD daily. Participants will take medication by mouth with food in the morning and evening.
Placebo
Participants in this Arm will take a medically inert placebo. Participants will take medication by mouth with food in the morning and evening.
Eligibility Criteria
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Inclusion Criteria
2. Regular use (at least 4 times per week) of cannabis concentrates for the last year.
3. Not currently seeking to cut down or stop cannabis use.
4. 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.
5. At least two symptoms of a DSM-5 cannabis use disorder.
Exclusion Criteria
2. Use of CBD-containing products other than cannabis concentrates in the past 90 days.
3. 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.
4. Daily nicotine use.
5. 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.
6. Current cardiovascular or respiratory disease (e.g., coronary artery disease, severe asthma, chronic obstructive pulmonary disease, etc.)
7. Current use of any psychotropic (e.g., antidepressants, anxiogenics) or hepatotoxic medications.
8. 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.
11. 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.
12. 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.
13. For female participants, currently lactating.
14. 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).
15. 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".
25 Years
60 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Joseph P Schacht, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23-0953
Identifier Type: -
Identifier Source: org_study_id
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