Cannabidiol and Cannabis Concentrate Users

ConditionCannabis Use Disorder

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age25-60

SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Broad Spectrum Cannabidiol (bsCBD) 400 mg
Drug
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
Drug
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
Drug
Participants in this Arm will take a medically inert placebo. Participants will take medication by mouth with food in the morning and evening.

Treatment groups

120 Participants

are divided into 3 treatment groups

Group A: Broad Spectrum Cannabidiol (bsCBD) 400 mgActive comparator 1 intervention

Group B: Broad Spectrum Cannabidiol (bsCBD) 200 mgActive comparator 1 intervention

Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

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

Time frame

4 weeks

Difference in cannabis use

Total number of days of cannabis use during the 4-week medication period as reported on daily diaries

Time frame

4 weeks

Secondary outcomes

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)

Time frame

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)

Time frame

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)

Time frame

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)

Time frame

4 weeks

Other outcomes

Difference in blood cannabidiol (CBD) levels

CBD levels in blood samples collected at baseline, Week 2, and Week 4 of medication ingestion

Time frame

4 weeks

Adverse effects

Adverse effects reported at baseline and Week 4 of medication ingestion

Time frame

4 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov

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