Health TrialsbyHealthPanel

Effect of Cannabis on Cigarette Use Behavior

ConditionsCannabis UseTobacco UseCigarette Smoking
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21+
SponsorJohns Hopkins University

About this trial

The purpose of this study is to determine the impact of tetrahydrocannabinol (THC) administration on motivational, subjective, and physiological effects of cigarettes. The study's goals are to test demand for cigarettes, tobacco craving, affect, heart rate, blood pressure, expired breath carbon monoxide, and cognitive performance. Researchers will compare multiple doses of THC and a placebo in participants who smoke cigarettes and either smoke or vape THC in the laboratory.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy non-treatment seeking adults aged 21 or older

Report daily use of combustible tobacco cigarettes

Biological confirmation of cigarette use: have an expired carbon monoxide (CO) level of more than 5 ppm and a positive urine cotinine test at screening

Report current use of cannabis (at least 1 occasion per week)

Disqualifiers

Report current intention to reduce or quit cannabis or tobacco use within the next 30 days

Meet Diagnostic and Statistical Manual (DSM-5) criteria for a substance use disorder other than alcohol, cannabis, or nicotine

Test positive for illicit drugs other than cannabis and tobacco

Positive breath alcohol test at study admission

Trial design

Design model

Factorial

Treatments tested in this trial

  • THC 30mg

    Drug

    High dose of THC (30 mg)

  • THC 5mg

    Drug

    Low dose of THC (5 mg)

  • THC 0mg

    Drug

    Placebo dose of THC (0 mg)

  • Cigarette Full Nicotine

    Drug

    Full nicotine cigarette

  • Cigarette Reduced Nicotine

    Drug

    Reduced nicotine cigarette

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Smoked THCExperimental treatment 5 interventions
Group B: Vaporized THCExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Demand Intensity

Consumption of cigarette puffs at unconstrained price as measured by an incentivized demand task. Minimum value is 0, maximum value is not constrained. Higher scores indicate more consumption at unconstrained price (a worse outcome).

Time frame
45 minutes after THC or placebo administration
2

Demand Elasticity

Changes in cigarette consumption with changes in price as measured by an incentivized demand task. There is no minimum or maximum value. Higher scores indicate greater cigarette price sensitivity (a better outcome).

Time frame
45 minutes after THC or placebo administration

Secondary outcomes

1

Minnesota Nicotine Withdrawal Scale (MNWS)

A subjective effect measure of nicotine withdrawal. Minimum value is 0, maximum value is 68. Higher scores indicate greater nicotine withdrawal (a worse outcome). Primary outcomes will be the peak change from baseline.

Time frame
Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
2

Brief Questionnaire of Smoking Urges (QSU - Brief) Factor 1

Self report assessment smoking urges. Factor 1 - Intention/Desire to Smoke. Score minimum is 7, Score Maximum is 35. Primary outcomes will be the peak change from baseline.

Time frame
Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
3

Brief Questionnaire of Smoking Urges (QSU - Brief) Factor 2

Self report assessment smoking urges. Factor 2 - Relief of Negative Affect \& Urgent Desire to Smoke. Score minimum is 7, Score Maximum is 35. Primary outcomes will be the peak change from baseline.

Time frame
Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.
4

Drug Effect Questionnaire for Like Drug

The Drug Effect Questionnaire will be administered using a visual analog scale. Participants place a mark on a 100mm line with the left endpoint labeled Not at All and the right endpoint labeled Extremely. Primary outcomes will be the peak change from baseline.

Time frame
Baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours post THC or placebo administration.

Other outcomes

Sponsors and contacts

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

Johns Hopkins University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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