Status:
COMPLETED
Effect of AEF0117 on Treatment-seeking Patients With Cannabis Use Disorder (CUD)
Lead Sponsor:
Aelis Farma
Conditions:
Marijuana Abuse
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Cannabis use is increasing and will only further escalate with legalization of recreational and medical cannabis use in western countries , with a prevalence greater than 30 % in the US and most Europ...
Detailed Description
Cannabis use is increasing and will only further escalate with legalization of recreational and medical cannabis use in western countries , with a prevalence greater than 30 % in the US and most Europ...
Eligibility Criteria
Inclusion
- Male or female subjects between 18 and 65 years old, both inclusive.
- Subjects must meet DSM-5 criteria for moderate to severe CUD as assessed by the standard MINI-5.
- Subjects must be treatment-seeking and have a mean cannabis use of ≥5 days per week within the last 4 weeks at the screening and baseline visit of the study. Mean cannabis use is assessed by the TLFB and a positive urine concentration test (creatinine-normalized \[THC-COOH\] ≥50 ng/mL).
- Subjects must use inhalation (i.e., smoking, vaping) consistently as the primary route of cannabis administration. Additional use of edible cannabis is allowed.
- Written informed consent to participate in the study.
- Body mass index (BMI) between ≥18 and \<35 kg/m2, inclusive, by Nomograph for BMI at screening.
- Female subjects of childbearing potential, defined as having a menstrual cycle that is confirmed prior to enrollment, and who are heterosexually active and not surgically sterile or at least 2 years postmenopausal, must agree to use one of the following forms of contraception throughout the study and until 21 days after the last dose of study drug: abstinence, hormonal (oral, transdermal, implant, or injection), barrier (condom, diaphragm with spermicide), intrauterine device, or vasectomized partner (6 months minimum).
- Male subjects are to refrain from donating sperm and heterosexually active male subjects must agree to the use of highly effective contraceptive methods (e.g., double barrier with at least condoms and spermicide) from screening through 90 days after the last dose of study drug, or their female partner must use a highly effective method of contraception as listed in inclusion criteria 7 from screening through 90 days after the last dose.
- No clinically significant abnormal findings in the medical history, on physical examination, ECG, or clinical laboratory results (see Appendix B) during screening that could jeopardize the safety of the subject or impact the validity of the study.
- Subjects must agree to return to the study site as required, be able to read English, and be willing to comply with all required study procedures.
Exclusion
- A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or any other condition which, in the opinion of the principal investigator, would jeopardize the safety of the subject or impact the validity of the study results. For psychiatric disease, see more details below.
- Subject has had significant traumatic injury, major surgery, or open biopsy within 30 days prior to the screening visit.
- Presence or history within 12 months prior to screening of other substance use disorders according to DSM-5 criteria (as assessed by the MINI-5, psychiatric assessment, urine drug screen, breath analyzer, as appropriate) except for mild alcohol use disorder (as defined in DSM-5) or tobacco use disorder. Current use (within 30 days prior to screening) of opioid agonist or antagonist.
- Subjects meeting DSM-5 criteria for schizophrenia, schizoaffective illness, or bipolar disorder. Subjects experiencing psychotic events which require psychiatric intervention or would interfere with study participation, apart from transient psychotic events due to substance abuse.
- Subjects diagnosed with major depression and with a severity score of \>17 based on HAM-D. Furthermore, subjects with other psychiatric disorders (excluding CUD) and with either a severity score at baseline of \>4 based on CGI for other psychiatric disorders, or who have not been stable for at least the last 3 months prior to screening with either behavioral treatment or unchanged medication and dose. Subjects with a current psychiatric disorder treated with prohibited medications .
- Subjects with a history of or current homicidal ideations or attempts.
- Subjects with any suicidal behavior or answering 'yes' to question 4 or 5 on suicidal ideation within the past 2 years based on the Baseline/Screening version of the C-SSRS. Subjects with any suicidal behavior or answering 'yes' to question 4 or 5 on suicidal ideation longer than 2 years ago based on the Baseline/Screening version of the C-SSRS and who, in the opinion of the principal investigator, could be at risk of jeopardizing his/her own safety during the study
- Subjects who use daily supplements of steroids (or food containing steroids), including pregnenolone, during the 4 weeks prior to the first screening visit. Topical use of steroids is allowed, and hormonal contraceptives are allowed if using a stable regimen throughout the study.
- Subjects with frequent regular use of diet or supplements (e.g., St. John's Wort), food or grapefruit juice that may interfere with the activities of CYP P450.
- Participation in a clinical trial within 1 month prior to the first dose of study drug, or 2 months if terminal half-life of the investigational drug is more than 120 hours.
- Female subjects who are trying to conceive, are pregnant, are lactating or have a positive serum pregnancy test at screening or a positive urine pregnancy test at study visits, regardless of childbearing potential.
- A positive urine drug screen for other drugs of abuse other than cannabinoids and/or a positive breath test for alcohol. One repeat alcohol breath test is allowed at a second screening visit or at the baseline visit.
- Subjects with known allergy to corn or corn derivatives.
- Legal status of the subject that in the opinion of the investigator would interfere with participation, e.g., risk of incarceration.
- Subjects taking any of the medications or substances
Key Trial Info
Start Date :
May 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2024
Estimated Enrollment :
333 Patients enrolled
Trial Details
Trial ID
NCT05322941
Start Date
May 6 2022
End Date
July 22 2024
Last Update
July 30 2024
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Cedar clinical research
Phoenix, Arizona, United States, 85021
2
CenExel CNR
Garden Grove, California, United States, 82845
3
UCLA Department of Psychiatry and Biobehavioral Sciences
Los Angeles, California, United States, 90095
4
Yale Stress Center - Addiction Program
New Haven, Connecticut, United States, 06520