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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02961309
Recruitment Status : Active, not recruiting
First Posted : November 10, 2016
Last Update Posted : June 14, 2019
Information provided by (Responsible Party):
Battelle Memorial Institute

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.

Condition or disease Intervention/treatment Phase
Tobacco Use Drug: THC Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: A Laboratory Model of Increasing THC Potency on Cigarette Smoking
Actual Study Start Date : May 7, 2018
Actual Primary Completion Date : April 24, 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana Smoking

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Puff topography of tobacco cigarette smoked [ Time Frame: 30 minutes post-marijuana smoking ]
    Mean total puff volume

Secondary Outcome Measures :
  1. Boost in exhaled breath carbon monoxide after smoking tobacco cigarette [ Time Frame: 30 minutes post-marijuana smoking ]
    Pre- to post-tobacco cigarette smoking difference in exhaled breath carbon monoxide

  2. Self-reported urge to smoke tobacco cigarette [ Time Frame: 30 minutes post marijuana smoking ]
    Pre- to post-tobacco cigarette smoking difference in scores on the Questionnaire of Smoking Urge

  3. Self-reported subjective effects related to tobacco cigarette smoking [ Time Frame: 30 minutes post marijuana smoking ]
    Pre- to post-tobacco cigarette smoking difference in the Nicotine-Drug Effects Questionnaire

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  1. Meets Diagnostic and Statistical Manual-5 (DSM-5) criteria for current (i.e., past year) or past (i.e., lifetime) cannabis use disorder;
  2. Meets DSM-5 criteria for any current Axis I disorder, other than tobacco use disorder;
  3. 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;
  4. Self-reported asthma or chronic obstructive pulmonary disease; and
  5. Among females, current pregnancy or lactation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02961309

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United States, Maryland
Battelle Memorial Institute
Baltimore, Maryland, United States, 21209
Sponsors and Collaborators
Battelle Memorial Institute
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Principal Investigator: Wallace Pickworth, PhD Battelle

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Responsible Party: Battelle Memorial Institute Identifier: NCT02961309     History of Changes
Other Study ID Numbers: BMI-73659
First Posted: November 10, 2016    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Battelle Memorial Institute:
tobacco cigarette

Additional relevant MeSH terms:
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Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists