AEF0117 for Cannabis Abuse

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cannabis AbuseAEF0117 - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will help study how well a new drug, AEF0117, works in people with cannabis abuse disorders.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: up to 16 weeks (end of study)

Week 16
Assesment of Quality of life
Assessment of Marijuana Craving
Assessment of Quality of sleep
Assessment of cannabis use
Assessment of desire to quit cannabis
Assessment of severity of nicotine dependence
Complete psychiatric diagnosis
Measures subject-rated intensity of withdrawal symptoms

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

AEF0117
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

330 Total Participants · 2 Treatment Groups

Primary Treatment: AEF0117 · Has Placebo Group · Phase 2

AEF0117
Drug
Experimental Group · 1 Intervention: AEF0117 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo oral capsule · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AEF0117
2017
Completed Phase 2
~70

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 16 weeks (end of study)

Who is running the clinical trial?

Aelis FarmaLead Sponsor
8 Previous Clinical Trials
299 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,248 Previous Clinical Trials
2,028,757 Total Patients Enrolled
8 Trials studying Cannabis Abuse
1,538 Patients Enrolled for Cannabis Abuse
Jennifer Potter, MDPrincipal InvestigatorDepartment of Psychiatry and Behavioral Sciences at UT Health San Antonio.
1 Previous Clinical Trials
1,100 Total Patients Enrolled
Olga Lapeyra, MDPrincipal InvestigatorBehavioral Clinical Research
Larissa Mooney, MDPrincipal InvestigatorUCLA Department of Psychiatry and Biobehavioral Sciences
Rajita Sinha, MDPrincipal InvestigatorYale Stress Center - Addiction Program
Paul Thielking, MDPrincipal InvestigatorCedar Associates LLC
Frances Levin, MDPrincipal InvestigatorColumbia University/NYSPI
Jennifer Wisdom, MDPrincipal InvestigatorCODA, Inc Research Department
Kevin Gray, MDPrincipal InvestigatorAddiction Sciences Division Department of Psychiatry and Behavioral Sciences Medical University of South Carolina
1 Previous Clinical Trials
140 Total Patients Enrolled
Richi Kakar, MDPrincipal InvestigatorSegal Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are between 18 and 65 years old.
You have given written informed consent to participate in the study.\n
BMI between 18 and 35 kg/m2, inclusive, by Nomograph for BMI at screening.
Subjects must agree to return to the study site as required, be willing to comply with all required study procedures, and be able to read English.
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.
Subjects must be female, of childbearing potential, and must be heterosexually active and not surgically sterile or at least 2 years postmenopausal.