RECRUITINGPhase 1

Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study II

The purpose of the study is to characterize the acute effects of cannabinoids in women relative to men and to begin probing the mechanisms that may underlie gender differences.

Sponsor

Yale University

Enrollment

100 participants

Sites

1 locations

Start Date

October 2019

Completion

December 2027

CannabisInhaled THCPlacebo

Enrollment & Timeline

Recruiting

Target enrollment (estimated)

Target N

100

participants

Sites

locations

Duration

8.2 years

total trial span

Rate

pts/month needed

Oct 2019Month 82 of 98Dec 2027

84% of trial timeline elapsed16 months to primary endpoint

At 1 sites, each site needs to enroll approximately 1.0 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

Ask AI

Primary Outcomes

Change from Baseline: Rewarding Effects measured by Visual Analog Scale (VAS)

Changes in "high" assessed over the following timepoints: baseline, +60, +80, +120, +180, +300 minutes after start of oral Dronabinol administration.

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Fetching protocol from ClinicalTrials.gov…

RECRUITINGPhase 1

Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study II

The purpose of the study is to characterize the acute effects of cannabinoids in women relative to men and to begin probing the mechanisms that may underlie gender differences.

Sponsor

Yale University

Enrollment

100 participants

Sites

1 locations

Start Date

October 2019

Completion

December 2027

CannabisInhaled THCPlacebo

Enrollment & Timeline

Recruiting

Target enrollment (estimated)

Target N

100

participants

Sites

locations

Duration

8.2 years

total trial span

Rate

pts/month needed

Oct 2019Month 82 of 98Dec 2027

84% of trial timeline elapsed16 months to primary endpoint

At 1 sites, each site needs to enroll approximately 1.0 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

Ask AI

Primary Outcomes

Change from Baseline: Rewarding Effects measured by Visual Analog Scale (VAS)

Changes in "high" assessed over the following timepoints: baseline, +60, +80, +120, +180, +300 minutes after start of oral Dronabinol administration.

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

all

Healthy Volunteers

Yes

View full criteria

Inclusion Criteria:

* At least one lifetime exposure to cannabis
* Good physical and mental health

Exclusion Criteria:

* Cannabis naïve individuals
* Major current or recent stressors

Ask AI

Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study II

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study II

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Eligibility

Trial Sites (1)