Verified November 2016 by Battelle Memorial Institute
Sponsor:
Information provided by (Responsible Party):
Dr. Erica Peters, Battelle Memorial Institute
ClinicalTrials.gov Identifier:
NCT02961309
First received: November 2, 2016
Last updated: November 9, 2016
Last verified: November 2016
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.
| Tobacco Use | Drug: THC | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science |
| Official Title: | A Laboratory Model of Increasing THC Potency on Cigarette Smoking |
- Number of tobacco cigarettes smoked [ Time Frame: 3 hours post-marijuana smoking ] [ Designated as safety issue: No ]
- Latency to first tobacco cigarette smoked [ Time Frame: 30 minutes post-marijuana smoking ] [ Designated as safety issue: No ]
- Mean puff topography of tobacco cigarettes smoked [ Time Frame: 3 hours post marijuana smoking ] [ Designated as safety issue: No ]
- Mean exhaled breath carbon monoxide of tobacco cigarettes smoked [ Time Frame: 3 hours post marijuana smoking ] [ Designated as safety issue: No ]
- Self-reported urge to smoke tobacco cigarette [ Time Frame: 30 minutes post marijuana smoking ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 7 |
| Study Start Date: | January 2017 |
| Estimated Study Completion Date: | September 2017 |
| Estimated Primary Completion Date: | April 2017 (Final data collection date for primary outcome measure) |
| Experimental: Active THC
5.6% THC via smoked marijuana cigarette |
Drug: THC
1 High-Potency THC (Dosage = 10mg) cigarette (oral smoking) on one day and 1 Placebo on the other day. Other Name: marijuana |
| Experimental: Placebo
Placebo THC via smoked cigarette |
Drug: THC
1 High-Potency THC (Dosage = 10mg) cigarette (oral smoking) on one day and 1 Placebo on the other day. Other Name: marijuana |
The study requires a total of three visits to Battelle’s laboratory: one screening visit and two experimental visits. The screening visit will determine eligibility into the study. If eligible, participants will smoke a tobacco cigarette through the Clinical Research Support System (CReSS) puff topography device. Enrolled participants will attend two separate 5-hour experimental visits. Participants will be randomly assigned the order of THC potency (active or placebo), with the assignment blocked by sex. When participants arrive at the laboratory for each visit, they will provide biologic samples to verify compliance with pre-study instructions and then will be taken to a specially ventilated smoking chamber. They will be connected to a continuously-monitoring heart rate and blood pressure machine so that their vital signs can be observed throughout the smoking session. A research assistant will give a marijuana cigarette to the participant. A research assistant will light the cigarette and then exit the room. Participants will follow tape-recorded instructions for smoking the marijuana cigarette through the CReSS device. Upon completion of smoking the marijuana cigarette, participants will complete the Tobacco Craving Questionnaire via paper and pencil and will then be allowed to smoke one of his own tobacco cigarettes through the CReSS puff topography device. Participants will be allowed to smoke as many tobacco cigarettes as they would like for the next 3 hours. Participants will then be given lunch and sent home via taxicab. All participants will receive both potencies (i.e., active and placebo) of marijuana. The active potency of marijuana will be 5.6% THC.
| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02961309
Battelle Memorial Institute
| Principal Investigator: | Erica N Peters, PhD | Battelle |
| Responsible Party: | Dr. Erica Peters, Principal Research Scientist, Battelle Memorial Institute |
| ClinicalTrials.gov Identifier: | NCT02961309 History of Changes |
| Other Study ID Numbers: | BMI-73659 |
| Study First Received: | November 2, 2016 |
| Last Updated: | November 9, 2016 |
| Health Authority: | United States: Food and Drug Administration |
| Individual Participant Data | |
| Plan to Share IPD: | No |
Keywords provided by Battelle Memorial Institute:
| THC marijuana tobacco cigarette smoking |
Additional relevant MeSH terms:
| Cannabinoid Receptor Agonists Cannabinoid Receptor Modulators Dronabinol Hallucinogens Physiological Effects of Drugs Psychotropic Drugs Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on November 10, 2016