Effects of different forms of vaporized Cannabis sativa L. Afina in cannabis users

Completed

Conditions: no health condition is addressed in the research, and healthy volunteers who are occasional cannabis users will be recruited
n.a.

Registration Number: NL-OMON50058

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

• Occasional cannabis users (>10 lifetime exposures and <= 2 times/week in the
previous 3 months)
• Age between 18-50
• Good physical health as determined by medical examination and laboratory
analysis
• Absence of any major medical, endocrine and neurological condition
• Normal weight, body mass index (weight/height2) between 18 and 30 kg/m2
• Written Informed Consent

Exclusion Criteria

• History of drug abuse (other than the use of cannabis) or addiction
(determined by the medical questionnaire, drug questionnaire and medical
examination)
• Pregnancy or lactation (pregnancy test, if needed)
• Hypertension (diastolic > 90; systolic > 140)
• Current or history of psychiatric disorder (determined by the medical
questionnaire and medical examination)
• Liver dysfunction
• Any serious prior adverse response to cannabis
• History of cardiac dysfunctions (e.g. arrhythmia, ischemic heart disease)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The inhalation process and the overall satisfaction with the use of the IMPs<br /><br>will be assessed by the means of Likert scales. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Subjective drug effects will be measured by a series of VAS/Bowdle<br /><br>questionnaire/CADDS. The assessment of the quality of the IMPs by participants<br /><br>will be measured by a series of Likert scales. Cognition will be assessed by a<br /><br>computerized test battery. Memory, i.e. sensitivity to go along with suggested<br /><br>self-incriminating statements will be assessed using an adjusted false<br /><br>confession paradigm.</p><br>