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| ID | Type | Description | Link |
|---|---|---|---|
| R21DA044377 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study will evaluate the individual and interactive pharmacokinetic and pharmacodynamic effects of smoked cannabis and nicotine.
The proposed study will be conducted at the Johns Hopkins Behavioral Pharmacology Research Unit (BPRU). All participants will be healthy adult volunteers who are regular nicotine/tobacco users, and have prior experience with cannabis use. Participants will complete seven outpatient experimental test sessions (completed in a randomized order), under double-blind conditions in which participants will first self-administer smoked cannabis (either active or placebo), followed by nicotine (via a tobacco cigarette or an e-cigarette); there will also be one condition in which participants smoke active cannabis alone (without subsequent nicotine use). Nicotine self-administration will occur in an ad libitum fashion for 5 hours. Nicotine products will be the individual participant's preferred brand of cigarettes or the commercial pod-style e-cigarette the JUUL (pods will contain either 3% or 5% nicotine pods). Active cannabis will contain 10 mg tetrahydrocannabinol (THC) while placebo will contain 0 mg THC. During the ad libitum nicotine/tobacco-use period, various puffing behaviors (e.g., puff volume, puff duration, puff number, inter-puff-interval) will be measured using specialized equipment. Acute subjective effects of cannabis/nicotine, cannabis/nicotine withdrawal symptoms, craving, vital signs, and cognitive/psychomotor performance will also be assessed throughout the experimental sessions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active cannabis without nicotine | Experimental | Smoked cannabis containing 10mg THC + No nicotine/tobacco |
|
| Active cannabis with own brand cigarettes | Experimental | Smoked cannabis containing 10mg THC + ad-libitum use of preferred brand cigarettes |
|
| Active cannabis with low nicotine e-cigarette | Experimental | Smoked cannabis containing 10mg THC + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL) |
|
| Active cannabis with high nicotine e-cigarette | Experimental | Smoked cannabis containing 10mg THC + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL) |
|
| placebo cannabis with own brand cigarettes | Experimental | Smoked placebo cannabis + ad-libitum use of preferred brand cigarettes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabis | Drug | Cannabis will be smoked |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Nicotine (mL of Smoke/Vapor) Inhaled | Amount of nicotine used (determined by total volume (mL) of cigarette smoke or JUUL vapor inhaled) after cannabis exposure in each session. | 0-5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Peak Change From Baseline Self-reported Drug Effect as Assessed by the Drug Effect Questionnaire (DEQ) | Mean Peak Change From Baseline rating (0-100) of Drug Effect on the DEQ, with 0 being no effect and 100 being maximum effect. | 0-5 hours |
| Mean Peak Change From Baseline Psychomotor Performance as Assessed by the Digit Symbol Substitution Task (DSST) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Vandrey | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21224 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cannabis With and Without Nicotine | This was a within-subjects, cross-over design in which all participants were exposed to all 7 conditions in a randomized order. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
We are reporting data for study completers. 20 participants completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cannabis With and Without Nicotine | This was a within-subjects, cross-over design in which all participants were exposed to all 7 conditions in a randomized order. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Amount of Nicotine (mL of Smoke/Vapor) Inhaled | Amount of nicotine used (determined by total volume (mL) of cigarette smoke or JUUL vapor inhaled) after cannabis exposure in each session. | Represents study completers | Posted | Mean | Standard Deviation | Volume in mL | 0-5 hours |
|
0-5 hours
International Council for Harmonization (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Cannabis Without Nicotine | Smoked cannabis containing 10mg THC + No nicotine/tobacco Cannabis: Cannabis will be smoked |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomitting | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ryan Vandrey | Johns Hopkins School of Medicine | 410-550-4036 | rvandrey@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 15, 2022 | Jan 18, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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All participants will complete all dose conditions (study arms) in a randomized order
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placebo controlled, double-blind
| Placebo cannabis with low nicotine e-cigarette |
| Experimental |
Smoked placebo cannabis + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL) |
|
| Placebo cannabis with high nicotine e-cigarette | Experimental | Smoked placebo cannabis + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL) |
|
| Nicotine | Drug | Nicotine will be smoked or vaporized |
|
Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Total correct trials in 90-seconds. Minimum score of 0 but no maximum score (higher scores indicate better performance). |
| 0-5 hours |
| Mean Peak Change From Baseline Working Memory Performance as Assessed by the Paced Auditory Serial Addition Task (PASAT) | Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. Total correct trials out of 90 recorded is primary outcome (higher scores indicate better performance). | 0-5 hours |
| Mean Peak Change From Baseline Behavioral Task Performance as Assessed by the DRUID App | Behavioral task performance will be assessed with the DRUID app's Global impairment score (range 0-100), where lower scores indicate better performance. | 0-5 hours |
| Mean Peak Change From Baseline Tobacco Craving as Assessed by the Tobacco Craving Questionnaire | Mean peak change from baseline rating (0-100) of "Craving" with 0 being no craving and 100 being maximum craving. | 0-5 hours |
| Mean Peak Change From Baseline Cannabis Craving as Assessed by the Cannabis Craving Questionnaire | Mean peak change from baseline rating (0-100) of "Craving" with 0 being no craving and 100 being maximum craving | 0-5 hours |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | Active Cannabis With Low Nicotine E-cigarette | Smoked cannabis containing active THC + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL) Cannabis: Cannabis will be smoked Nicotine: Nicotine will be smoked or vaporized |
| OG003 | Active Cannabis With High Nicotine E-cigarette | Smoked cannabis containing active THC + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL) Cannabis: Cannabis will be smoked Nicotine: Nicotine will be smoked or vaporized |
| OG004 | Placebo Cannabis With Own Brand Cigarettes | Smoked placebo cannabis + ad-libitum use of preferred brand cigarettes Cannabis: Cannabis will be smoked Nicotine: Nicotine will be smoked or vaporized |
| OG005 | Placebo Cannabis With Low Nicotine E-cigarette | Smoked placebo cannabis + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL) Cannabis: Cannabis will be smoked Nicotine: Nicotine will be smoked or vaporized |
| OG006 | Placebo Cannabis With High Nicotine E-cigarette | Smoked placebo cannabis + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL) Cannabis: Cannabis will be smoked Nicotine: Nicotine will be smoked or vaporized |
|
|
| Secondary | Mean Peak Change From Baseline Self-reported Drug Effect as Assessed by the Drug Effect Questionnaire (DEQ) | Mean Peak Change From Baseline rating (0-100) of Drug Effect on the DEQ, with 0 being no effect and 100 being maximum effect. | Represents study completers | Posted | Mean | Standard Deviation | score on a scale | 0-5 hours |
|
|
|
| Secondary | Mean Peak Change From Baseline Psychomotor Performance as Assessed by the Digit Symbol Substitution Task (DSST) | Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Total correct trials in 90-seconds. Minimum score of 0 but no maximum score (higher scores indicate better performance). | Represents study completers | Posted | Mean | Standard Deviation | Total correct trials | 0-5 hours |
|
|
|
| Secondary | Mean Peak Change From Baseline Working Memory Performance as Assessed by the Paced Auditory Serial Addition Task (PASAT) | Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. Total correct trials out of 90 recorded is primary outcome (higher scores indicate better performance). | Represents study completers | Posted | Mean | Standard Deviation | Total correct trials | 0-5 hours |
|
|
|
| Secondary | Mean Peak Change From Baseline Behavioral Task Performance as Assessed by the DRUID App | Behavioral task performance will be assessed with the DRUID app's Global impairment score (range 0-100), where lower scores indicate better performance. | Represents study completers | Posted | Mean | Standard Deviation | score on a scale | 0-5 hours |
|
|
|
| Secondary | Mean Peak Change From Baseline Tobacco Craving as Assessed by the Tobacco Craving Questionnaire | Mean peak change from baseline rating (0-100) of "Craving" with 0 being no craving and 100 being maximum craving. | Represents study completers | Posted | Mean | Standard Deviation | score on a scale | 0-5 hours |
|
|
|
| Secondary | Mean Peak Change From Baseline Cannabis Craving as Assessed by the Cannabis Craving Questionnaire | Mean peak change from baseline rating (0-100) of "Craving" with 0 being no craving and 100 being maximum craving | Represents study completers | Posted | Mean | Standard Deviation | score on a scale | 0-5 hours |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Active Cannabis With Own Brand Cigarettes | Smoked cannabis containing 10mg THC + ad-libitum use of preferred brand cigarettes Cannabis: Cannabis will be smoked Nicotine: Nicotine will be smoked or vaporized | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Active Cannabis With Low Nicotine E-cigarette | Smoked cannabis containing 10mg THC + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL) Cannabis: Cannabis will be smoked Nicotine: Nicotine will be smoked or vaporized | 0 | 24 | 0 | 24 | 1 | 24 |
| EG003 | Active Cannabis With High Nicotine E-cigarette | Smoked cannabis containing 10mg THC + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL) Cannabis: Cannabis will be smoked Nicotine: Nicotine will be smoked or vaporized | 0 | 22 | 0 | 22 | 0 | 22 |
| EG004 | Placebo Cannabis With Own Brand Cigarettes | Smoked placebo cannabis + ad-libitum use of preferred brand cigarettes Cannabis: Cannabis will be smoked Nicotine: Nicotine will be smoked or vaporized | 0 | 21 | 0 | 21 | 1 | 21 |
| EG005 | Placebo Cannabis With Low Nicotine E-cigarette | Smoked placebo cannabis + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL) Cannabis: Cannabis will be smoked Nicotine: Nicotine will be smoked or vaporized | 0 | 22 | 0 | 22 | 0 | 22 |
| EG006 | Placebo Cannabis With High Nicotine E-cigarette | Smoked placebo cannabis + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL) Cannabis: Cannabis will be smoked Nicotine: Nicotine will be smoked or vaporized | 0 | 21 | 0 | 21 | 0 | 21 |
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| D006573 |
| Heterocyclic Compounds, 1-Ring |