A Laboratory Model of Increasing Delta-9-tetrahydrocannabinol (THC) Potency on Cigarette Smoking

NCT02961309 | Completed Phase 1 FDA Drug

• 1 other identifier: BMI-73659
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the proposed research is to investigate how smoking increasing potency of THC (i.e., the psychoactive ingredient in marijuana) changes tobacco cigarette smoking behavior, urges, subjective effects, and abuse liability. This study will be a within-subjects, placebo-controlled study in our clinical laboratory of the effect of active vs. placebo marijuana on cigarette puff topography, exhaled carbon monoxide, urge, subjective effects, and abuse liability among 7 adults who smoke both marijuana and tobacco cigarettes.

Conditions

Tobacco Use

Keywords

THC; marijuana; tobacco cigarette; smoking

Outcome Measures

Primary Outcomes (1)

• Puff topography of tobacco cigarette smoked

  Mean total puff volume

  30 minutes post-marijuana smoking

Secondary Outcomes (3)

• Boost in exhaled breath carbon monoxide after smoking tobacco cigarette

  30 minutes post-marijuana smoking

• Self-reported urge to smoke tobacco cigarette

  30 minutes post marijuana smoking

• Self-reported subjective effects related to tobacco cigarette smoking

  30 minutes post marijuana smoking

Study Arms (2)

Active THC

EXPERIMENTAL

5.6% THC via smoked marijuana cigarette

Drug: THC

Placebo

EXPERIMENTAL

Placebo THC via smoked cigarette

Drug: THC

Interventions

THC DRUG

1 High-Potency THC (Dosage = 10mg) cigarette (oral smoking) on one day and 1 Placebo on the other day.

Also known as: marijuana

Active THC; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current US resident;
• Age ≥ 18 years;
• Self-reported smoking of marijuana no more than three days per week within the past year;
• Self-report past-month smoking of marijuana;
• Self-report daily smoking of at least five cigarettes per day within the past year;
• Cotinine ≥ 100 ng/mL at the in-person screening visit; and
• Able to read, understand, and sign informed consent.

You may not qualify if:

• Meets Diagnostic and Statistical Manual-5 (DSM-5) criteria for current (i.e., past year) or past (i.e., lifetime) cannabis use disorder;
• Meets DSM-5 criteria for any current Axis I disorder, other than tobacco use disorder;
• Self-reported current desire to stop marijuana or tobacco use, defined as 7 or greater on an 11-rung (scaled of 1-10) Contemplation Ladder for each;
• Self-reported asthma or chronic obstructive pulmonary disease; and
• Among females, current pregnancy or lactation.

Sponsors & Collaborators

• Battelle Memorial Institute: lead

Study Sites (1)

Battelle Memorial Institute

Baltimore, Maryland, 21209, United States

Location

MeSH Terms

Conditions

Tobacco Use; Marijuana Abuse; Smoking

Interventions

Dronabinol; nabiximols

Condition Hierarchy (Ancestors)

Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Wallace Pickworth, PhD

  Battelle

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 10, 2016
• Study Start: May 7, 2018
• Primary Completion: April 24, 2019
• Study Completion: September 30, 2019
• Last Updated: October 2, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)