A Phase 2 interventional study of AEF0117 and Placebo oral capsule in Marijuana Abuse, sponsored by Aelis Farma. Completed at 11 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by Aelis Farma · Phase 2, Interventional, and Treatment
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 European countries for individuals between 16 and 24 years of age. Approximately 9 % of those who use cannabis will become addicted. The number goes up to about 1 in 6 among those who start using cannabis as teenagers and to 25 to 50 % among those who smoke cannabis daily. The consequences of cannabis abuse in the most prone population (14-25 years of age) are extremely serious, and may include addiction, altered brain development, poorer educational outcomes, cognitive impairment, lower income, greater welfare dependence, unemployment and lower relationship and life satisfaction. There are no available pharmacological treatments of cannabis use disorder (CUD). Thus, the development of safe and effective medications for the treatment of CUD is an urgent public health priority.
The preclinical efficacy and available ADMET (Administration, Distribution, Metabolism, Elimination and Toxicology) in animal and human data suggest that AEF0117, an investigational new study drug, could constitute a very efficacious and safe treatment for cannabis abuse disorders. The purpose of this research is to study how AEF0117 influences the subjective effects of cannabis in subjects with CUD. AEF0117 acts in the same parts of the brain as THC (tetrahydrocannabinol), the active ingredient of marijuana, and may temporarily alter some of cannabis's effects.
The safety and tolerability of AE0117 has been demonstrated in the clinical studies conducted to date. This study will provide additional data on the efficacy of AEF0117 on treatment-seeking subjects with moderate to severe CUD.
This is a phase 2b, randomized, double-blind, placebo-controlled, 4-arm, parallel-group, prospective, multicenter study. The overall purpose of this study is to assess the efficacy and safety of AEF0117 in subjects with moderate to severe CUD who are treatment-seeking. The primary objective of this study is to demonstrate that AEF0117 induces a greater proportion of RESPONDERS (i.e., subjects with a RESPONSE of ≤1 day of cannabis use per week) compared to placebo in treatment-seeking subjects with moderate to severe CUD, according to DSM-5 criteria.The secondary objectives are to investigate the proportion of subjects that reach various levels of reduction and how this influences their quality of life, and to evaluate the safety and tolerability of AEF0117. And the exploratory objectives of this study are to further evaluate the effect of AEF0117 on pattern of cannabis use and change in various signs and symptoms, and in addition to assess effects during the grace period and the entire treatment period.
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 European countries for individuals between 16 and 24 years of age. Approximately 9 % of those who use cannabis will become addicted. The number goes up to about 1 in 6 among those who start using cannabis as teenagers and to 25 to 50 % among those who smoke cannabis daily. The consequences of cannabis abuse in the most prone population (14-25 years of age) are extremely serious, and may include addiction, altered brain development, poorer educational outcomes, cognitive impairment, lower income, greater welfare dependence, unemployment and lower relationship and life satisfaction. There are no available pharmacological treatments of cannabis use disorder (CUD). Thus, the development of safe and effective medications for the treatment of CUD is an urgent public health priority.
The preclinical efficacy and available ADMET (Administration, Distribution, Metabolism, Elimination and Toxicology) in animal and human data suggest that AEF0117, an investigational new study drug, could constitute a very efficacious and safe treatment for cannabis abuse disorders. The purpose of this research is to study how AEF0117 influences the subjective effects of cannabis in subjects with CUD. AEF0117 acts in the same parts of the brain as THC (tetrahydrocannabinol), the active ingredient of marijuana, and may temporarily alter some of cannabis's effects.
The safety and tolerability of AE0117 has been demonstrated in the clinical studies conducted to date. This study will provide additional data on the efficacy of AEF0117 on treatment-seeking subjects with moderate to severe CUD.
This will be a phase 2b, randomized, double-blind, placebo-controlled, 4-arm, parallel-group, prospective, multicenter study. The overall purpose of this study is to assess the efficacy and safety of AEF0117 in subjects with moderate to severe CUD who are treatment-seeking. The overall purpose of this study is to assess the efficacy and safety of AEF0117 in subjects with moderate to severe CUD who are treatment-seeking.
Up to 330 eligible male or female subjects will be randomized into 1 of 4 treatment groups. Due to the difference in prevalence of CUD between males and females, the number of females enrolled is anticipated to be less than 1/3 of all subjects. Moreover, the number of female subjects to be enrolled will be limited via stratification ensuring that a maximum 80 females will be assigned to active treatment (i.e., to 1 of the AEF0117 treatment groups), considering the development stage of the compound.
Subjects will be randomized to 1 of 4 treatment groups:
The primary objective of this study is to demonstrate that AEF0117 induces a greater proportion of RESPONDERS (i.e., subjects with a RESPONSE of ≤1 day of cannabis use per week) compared to placebo in treatment-seeking subjects with moderate to severe CUD, according to DSM-5 criteria.
The secondary objectives are to investigate the proportion of subjects that reach various levels of reduction and how this influences their quality of life, and to evaluate the safety and tolerability of AEF0117.
The exploratory objectives of this study are to further evaluate the effect of AEF0117 on pattern of cannabis use and change in various signs and symptoms, and in addition to assess effects during the grace period and the entire treatment period.
The study consists of a screening period, a double-blind treatment period which includes a grace period and a treatment ascertainment period, and a follow-up period. The study will be conducted on an outpatient basis at the sites with a total of 27 visits per subject after screening for eligibility. During the 12-week treatment period, 25 visits will be performed: 1 weekly visit will include most of the scheduled assessments (13 full visits), while the second weekly visit will only include few assessments (12 short visits).Under certain circumstances, a short visit may be converted to a remote visit if it does not pose a risk to the safety of the subject as judged by the investigator.
During the 4-week follow-up period, 2 visits approximately 14 days apart will take place.
The double-blind randomized treatment period will consist of 2 periods: a 4-week grace period and an 8-week treatment ascertainment period. During both periods, subjects will attend standardized medical management sessions once a week with trained professionals (i.e., 12 visits in total).
During the grace period (Day 1 to Day 28), cannabis use will not be a criterion for characterization of non-responding subjects. This period will allow AEF0117 to reach plasma steady state and allow for behavioral changes. During the treatment ascertainment period (Day 29 to Day 84), any cannabis use will be taken into consideration to assign subjects as responders and non-responders.
All study visits will be conducted on an outpatient basis at the sites. Screening visit(s), weekly full visits during the grace period and treatment ascertainment period (13 visits) and visits every second week during follow up (2 visits) include extended assessments. In addition, 1 short visit per week is scheduled during the grace period and treatment ascertainment period (12 visits), including a few assessments (the second of the twice weekly visits).
Efficacy will be assessed using different observer-rated and self-reported scales.
Self-reported cannabis use will be monitored daily, prospectively by an Ecological Momentary Assessment (EMA) using a smartphone-based application and retrospectively by using the TLFB procedure.
The documentation of self-reported cannabis use will be based primarily on the EMA data and, in the case of missing data, on the TLFB data. In the case of a discrepancy, the more conservative data will be used (i.e., presence of an episode of use).
Adverse events will be monitored by research staff and medical observations and spontaneous reporting throughout the study. The grading system of adverse events used in this study will be the grading system proposed by Sibille M., et. al. Specifications on the grading system for clinical observations and ECG parameters will be based on the publication by Sibille M, Patat A, et al. Vital signs and laboratory parameters will be based on the FDA vaccine guidance (The Biologics Blood Vaccines Guidance Compliance, FDA).
188 studies on the registry are indexed under Marijuana Abuse; 26 are open to participants now.
This study's enrollment of 333 is above the median of 51 across 160 interventional studies indexed under Marijuana Abuse.
Browse Marijuana Abuse studies →Aelis Farma is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The current study tests 3 doses of AEF0117 (1.0, 0.3, and 0.1 mg).AEF0117 capsules ; dose range 0.1 to 1.0mg by mouth, once a day for 12 weeks.
Drug: AEF0117
corn oil capsules once a day for 12 weeks.
Drug: Placebo oral capsule
AEF0117 (1.0, 0.3, and 0.1 mg) capsules
Also known as: 3ß-(4-methoxybenzyloxy)pregn-5-en-20-one
Corn oil capsule manufactured to mimic AEF0117 capsule
Also known as: Placebo
Assessment of cannabis use
Cannabis use will be assessed using self-reporting and monitored daily, prospectively by an EMA using a smartphone-based application
Time frame: up to 16 weeks (end of study)
Assessment of cannabis use
Cannabis use will be assessed using self-reporting and monitored daily, by using the TLFB procedure at each visit. The TLFB will be used to corroborate data obtained with EMA evaluation of cannabis use.
Time frame: up to 16 weeks (end of study)
Measures subject-rated intensity of withdrawal symptoms
The 19-item version of the Cannabis Withdrawal Scale (CWS) that will be used measures subject-rated intensity of withdrawal symptoms as well as the amount of distress or impairment in functioning due to each symptom for the last 24 hours on a scale of 0 ("not at all") to 10 ("extremely"). The following statements describe how you have felt over the last 24 hours
Time frame: up to 16 weeks (end of study)
Complete psychiatric diagnosis
The MINI International Neuropsychiatric Interview (MINI-5) will be used in order to complete psychiatric diagnostic assessment to assess for CUD criteria in addition to other psychiatric disorders for eligibility.
Time frame: up to 16 weeks (end of study)
Assesment of Quality of life
the Patient-Reported Outcomes Measurement Information System-29 is a 29-item self-report measure to assess quality of life by assessing functioning and well-being in physical, mental, and social domains of health over the last 7 days.
Time frame: up to 16 weeks (end of study)
Assessment of Marijuana Craving
The Marijuana Craving Questionnaire-Short Form (MCQ-12) is a 12-item self-report measures subjects' craving for marijuana on a Likert scale of 1-7 and yields total scores and factor scores in the areas of compulsivity, emotionality, expectancy, and purposefulness.
Time frame: up to 16 weeks (end of study)
Assessment of Quality of sleep
The Medical Outcome Study - Sleep Scale (MOS-SS) is a 12-item measure for characterizing the quality of sleep over the past 4 weeks.
Time frame: up to 16 weeks (end of study)
Assessment of severity of nicotine dependence
The Fagerstrom Test for Nicotine Dependence is a 6 item self-report questionnaire assessing severity of nicotine dependence
Time frame: up to 16 weeks (end of study)
Assessment of desire to quit cannabis
the Motivation to Quit Ladder is a single item change ladder from 1 to 10, where 1 is "no desire to quit" and higher numbers are greater desire to quit
Time frame: up to 16 weeks (end of study)
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2022 to primary completion in Apr 2024, 23 months.
Of 11 phase 2 interventional studies under Marijuana Abuse, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 42. This study's 23 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lixosicone
Aelis Farma