Effect of AEF0117 on Treatment-seeking Patients With Cannabis Use Disorder (CUD): SICA 2: SPECIFIC SIGNALING INHIBITOR IN CANNABIS ADDICTION (SICA 2)
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|ClinicalTrials.gov Identifier: NCT05322941|
Recruitment Status : Recruiting
First Posted : April 12, 2022
Last Update Posted : January 26, 2023
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.
|Condition or disease||Intervention/treatment||Phase|
|Marijuana Abuse||Drug: AEF0117 Drug: Placebo oral capsule||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||330 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Up to 330 eligible male or female subjects will be randomized into 1 of 4 treatment groups. The number of females to be enrolled will be limited to ensure that a maximum of 80 female subjects are assigned to active treatment (i.e., to 1 of the AEF0117 treatment groups).
Subjects will be randomized to 1 of 4 treatment groups:
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group, Phase 2b Study in Treatment-seeking Patients With Cannabis Use Disorder to Assess the Efficacy, Safety, and Tolerability of AEF0117 in Reducing Cannabis Use|
|Actual Study Start Date :||May 6, 2022|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||November 2023|
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.
AEF0117 (1.0, 0.3, and 0.1 mg) capsules
Other Name: 3ß-(4-methoxybenzykoxy)pregn-5-en-20-one t)
Placebo Comparator: Placebo
corn oil capsules once a day for 12 weeks.
Drug: Placebo oral capsule
Corn oil capsule manufactured to mimic AEF0117 capsule
- Assessment of cannabis use [ Time Frame: up to 16 weeks (end of study) ]Cannabis use will be assessed using self-reporting and monitored daily, prospectively by an EMA using a smartphone-based application
- Assessment of cannabis use [ Time Frame: up to 16 weeks (end of study) ]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.
- Measures subject-rated intensity of withdrawal symptoms [ Time Frame: up to 16 weeks (end of study) ]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
- Complete psychiatric diagnosis [ Time Frame: up to 16 weeks (end of study) ]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.
- Assesment of Quality of life [ Time Frame: up to 16 weeks (end of study) ]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.
- Assessment of Marijuana Craving [ Time Frame: up to 16 weeks (end of study) ]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.
- Assessment of Quality of sleep [ Time Frame: up to 16 weeks (end of study) ]The Medical Outcome Study - Sleep Scale (MOS-SS) is a 12-item measure for characterizing the quality of sleep over the past 4 weeks.
- Assessment of severity of nicotine dependence [ Time Frame: up to 16 weeks (end of study) ]The Fagerstrom Test for Nicotine Dependence is a 6 item self-report questionnaire assessing severity of nicotine dependence
- Assessment of desire to quit cannabis [ Time Frame: up to 16 weeks (end of study) ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05322941
|Contact: Stephanie Monlezun||+33 7 89 56 36 firstname.lastname@example.org|
|Contact: Frances Levin, MD||+1 201-694-3565||Frances.Levin@nyspi.columbia.edu|
|United States, California|
|UCLA Department of Psychiatry and Biobehavioral Sciences||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Larissa Mooney, MD 310-794-1497 LMooney@mednet.ucla.edu|
|United States, Connecticut|
|Yale Stress Center - Addiction Program||Recruiting|
|New Haven, Connecticut, United States, 06520|
|Contact: Rajita Sinha, MD 203-737-3436 email@example.com|
|United States, Florida|
|Lauderhill, Florida, United States, 33319|
|Contact: Richi Kakar, MD 954-990-6326 firstname.lastname@example.org|
|Behavioral Clinical Research||Recruiting|
|Miami Lakes, Florida, United States, 33016|
|Contact: Olga Lapeyra, MD email@example.com|
|Principal Investigator: Olga Lapeyra, MD|
|United States, New York|
|The Substance Treatment and Research Service (S.T.A.R.S.) of Columbia University/NYSPI.||Recruiting|
|New York, New York, United States, 10032|
|Contact: Frances Levin, MD 201-694-3565 Frances.Levin@nyspi.columbia.edu|
|United States, Oregon|
|CODA, Inc Research Department||Recruiting|
|Portland, Oregon, United States, 97214|
|Contact: Jennifer Wisdom, PhD 971-202-7829 firstname.lastname@example.org|
|United States, South Carolina|
|Addiction Sciences Division Department of Psychiatry and Behavioral Sciences Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425-8640|
|Contact: Kevin Gray, MD 843-792-6330 email@example.com|
|United States, Texas|
|Department of Psychiatry and Behavioral Sciences at UT Health San Antonio.||Recruiting|
|San Antonio, Texas, United States, 78218|
|Contact: Potter Jennifer, MD 713-504-2244 firstname.lastname@example.org|
|United States, Utah|
|Cedar Clinical Research||Recruiting|
|Draper, Utah, United States, 84020|
|Contact: Paul Thielking, MD 385-501-6116 email@example.com|
|Principal Investigator:||Frances Levin, MD||Columbia University/NYSPI|
|Principal Investigator:||Jennifer Wisdom, MD||CODA, Inc Research Department|
|Principal Investigator:||Kevin Gray, MD||Addiction Sciences Division Department of Psychiatry and Behavioral Sciences Medical University of South Carolina|
|Principal Investigator:||Jennifer Potter, MD||Department of Psychiatry and Behavioral Sciences at UT Health San Antonio.|
|Principal Investigator:||Larissa Mooney, MD||UCLA Department of Psychiatry and Biobehavioral Sciences|
|Principal Investigator:||Rajita Sinha, MD||Yale Stress Center - Addiction Program|
|Principal Investigator:||Richi Kakar, MD||Segal Trials|
|Principal Investigator:||Paul Thielking, MD||Cedar Associates LLC|
|Principal Investigator:||Olga Lapeyra, MD||Behavioral Clinical Research|