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High Potency Cannabis: Acute and Protracted Effects

ConditionsAbuse CannabisPainPharmacokinetics
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-55
SponsorUniversity of California, Los Angeles

About this trial

The purpose of this research is to assess the effects of smoked cananbis when cannabis is smoked during periods of cannabis use as usual and after a brief period of abstinence.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

• Male or non-pregnant and non-lactating females aged 21-55 years

Report cannabis smoking near daily

Not currently seeking treatment for their cannabis use

Have a Body Mass Index from 18.5 - 34kg/m2.

Disqualifiers

Meeting DSM-V criteria for any substance use disorder other than cannabis, nicotine, caffeine

Do not have positive urine toxicology for cannabis use during screening

Evidence of severe psychiatric illness (e.g. mood or anxiety disorder with functional impairment or suicide risk, schizophrenia) judged by the study physician (and PI) to put the participant at greater risk of experiencing adverse events due to completion of study procedures, interfere with their ability to participate in the study, or their capacity to provide informed consent.

Report using other illicit drugs in the prior 4 weeks

Trial design

Design model

Crossover

Treatments tested in this trial

  • Placebo Comparator: Placebo

    Drug

    Placebo

  • Low dose THC

    Drug

    Smoked low dose THC

  • High dose THC

    Drug

    Smoked high dose THC

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Placebo Comparator: PlaceboPlacebo comparator 1 intervention
Group B: Low dose THCActive comparator 1 intervention
Group C: High dose THCActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Subject-rated drug effects of abuse liability

Subject ratings of "Good Drug Effect" as measured using a visual analog scale (1-100 mm)

Time frame
3 hours
2

Analgesia as measured using the Cold Pressor Test

Pain threshold assessed using the Cold Pressor Test (percent baseline)

Time frame
3 hours

Secondary outcomes

1

Pharmacokinetics of THC and metabolites

Peak plasma levels of THC (ng/ml)

Time frame
3 hours
2

Pharmacokinetics of THC and metabolites

Peak plasma levels of 11-OH-THC (ng/ml)

Time frame
3 hours

Other outcomes

Sponsors and contacts

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

University of California, Los Angeles

Lead sponsor

California Department of Cannabis Control (DCC)

Collaborator

Source ClinicalTrials.gov
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