CANNABIDIOL for Alcohol dependence

Inclusion criteria

• {"criterion_text":"- Age between 18 and 70 years\n- Patients meeting the diagnosis of an alcohol dependence according to the ICD10\n- Patients reporting alcohol craving as symptom of AD according to the ICD10 symptom definition\n- Ability of the individual to understand the character and the individual consequences of the clinical trial\n- Written informed consent (must be available before enrollment in the study)\n- Consent to random assignment\n- For women with childbearing potential (WOCBP) and males with partners with childbearing potential (CBP), use of a highly effective birth control method until one month after last IMP administration and negative pregnancy test at the time of enrolment"}

Exclusion criteria

• {"criterion_text":"- Current psychotic or bipolar disorder or current severe depressive episode with suicidal ideations\n- Current treatment with any of the following substances: Any investigational medicinal product, Opioid-containing Analgesics, Anti-obesity drugs, Anticonvulsants, Opioid-containing Antidiarrheal Agents, Antineoplastics, Antipsychotics (exception: episodic use of melperone, prothipendyl, pipamperone, promethazine and quetiapine are allowed), Antidepressants (exception: allowed, when being taken in stable dose for a minimum of 14 days prior to enrolment and/or doxepine in low doses [max. 75mg daily]), Opioid-containing Cough/cold agents, Systemical Steroids, Other anti-craving (e.g. Acamprosate) or aversive medication (e.g. disulfiram), THC- or CBD-containing medication, Antiretroviral medication (e.g., Efavirenz), Xanthines (e.g., Theophylline), General anesthetics (e.g., propofol), Hypericum perforatum, Antibiotics (e.g., Rifampin, Clarithromycin, Erythromycin)\n- Positive drug screening (amphetamines/ecstasy, opiates, cocaine, barbiturates)\n- Pregnancy, lactation or breastfeeding\n- Current severe somatic comorbidities: severe liver cirrhosis [stage: CHILD B or C]. epilepsy determined by medical history or prolonged or shortened QT intervals [determined by ECG]\n- Patients with elevated transaminase levels (GOT or GPT) above three times the upper limit normal (ULN) value with elevated bilirubin levels above twice the ULN value\n- History of hypersensitivity to the investigational medicinal product CBD and/or Naltrexone (trade names: Adepend, Naltrexon-Hcl neuraxpharm, Naltrexonhydrochlorid Accord) or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product CBD and/or Naltrexone\n- Participation in other clinical trials or observation period of competing clinical trials, respectively.\n- Acute suicidal tendency or acute endangerment of self and others"}

Primary endpoints

• {"endpoint_text":"- Difference of alcohol craving (Obsessive Compulsive Drinking Scale, OCDS-G) between baseline (visit 2, day -2) and end of treatment (visit 5, day 14)","definition_or_measurement_approach":"Measured using the Obsessive Compulsive Drinking Scale (OCDS-G); comparison of scores between baseline (visit 2, day -2) and end of treatment (visit 5, day 14)."}

Secondary endpoints

• {"endpoint_text":"- difference from baseline (visit 2, day -2) of OCDS-G craving scores to visits 4 (day 7), 6 (day 28), 7 (day 42), 8 (day 105), 9 (day 196);","definition_or_measurement_approach":"OCDS-G craving score changes from baseline to specified visits (days 7, 28, 42, 105, 196)."}
• {"endpoint_text":"- difference from baseline of Quality of life (WHO-QOL-BREF scores) to visits 5 (day 14), 6 (day 28), 7 (day 42), 8 (day 105), 9 (day 196);","definition_or_measurement_approach":"WHO-QOL-BREF instrument scores compared from baseline to visits at days 14, 28, 42, 105, 196."}
• {"endpoint_text":"- difference from baseline of depressive symptoms (BDI-II scores) to visit 5 (day 14).","definition_or_measurement_approach":"Beck Depression Inventory-II (BDI-II) score change from baseline to day 14 (visit 5)."}
• {"endpoint_text":"- difference from baseline of state and trait anxiety (STAI scores) to visit 5 (day 14).","definition_or_measurement_approach":"State-Trait Anxiety Inventory (STAI) score change from baseline to day 14 (visit 5)."}
• {"endpoint_text":"- patient reported outcomes (set of items) at visit 3 (day 1), 4 (day 7), 5 (day 14), 6 (day 28), 7 (day 42), 8 (day 105), 9 (day 196));","definition_or_measurement_approach":"Collection of patient-reported outcome items at the listed visits (days 1, 7, 14, 28, 42, 105, 196)."}
• {"endpoint_text":"- CBD plasma levels [visit 3 (day1) and 5 (day14)] (only for patients at CIMH site)","definition_or_measurement_approach":"Measurement of CBD plasma concentrations at visit 3 (day 1) and visit 5 (day 14); only at the CIMH site."}
• {"endpoint_text":"- time to relapse, cumulative alcohol use and percent heavy drinking days [visit 5 (day 14), 6 (day 28), 7 (day 42), 8 (day 105), 9 (day 196)]","definition_or_measurement_approach":"Time-to-relapse metrics, cumulative alcohol consumption and percent heavy drinking days assessed at visits on days 14, 28, 42, 105, 196."}
• {"endpoint_text":"- Average weekly alcohol consumption and maximum weekly craving assessed every 7th day during the follow up period, starting after visit 5 (day 14) and continuing until visit 9 (day 196) (optional, only for patients that agree to use the study-specific app)","definition_or_measurement_approach":"Weekly self-reported average alcohol consumption and maximum weekly craving collected every 7 days via the study-specific smartphone app (optional, for consenting patients) from day 14 through day 196."}
• {"endpoint_text":"- differences of neural brain activation during presentation of alcohol cues, natural reward cues, presentation of emotional faces and neutral shapes, during inhibition of motor responses and during resting state from baseline (visit 2, day -2) to visit 5 (day 14) (only for patients at CIMH site)","definition_or_measurement_approach":"fMRI BOLD response and functional connectivity comparisons from baseline to day 14 during specified paradigms; only at CIMH site."}
• {"endpoint_text":"- differences of alcohol craving (visual analogue scale), response times, rates of errors, rates of correct responses and omission rates during the fMRI paradigms from baseline (visit 2, day -2) to visit 5 (day 14) (only for patients at CIMH site)","definition_or_measurement_approach":"Behavioural measures (VAS craving, response times, error rates, correct response rates, omissions) during fMRI paradigms compared baseline to day 14; only at CIMH site."}

Methods

• Use of site-based recruitment through participating clinical sites (listed trial sites in Germany).
• Printed recruitment materials: leaflets and posters (documents: K2_ICONICplus_Recruitment_Mat_leaflet, K2_ICONICplus_Recruitment_Mat_poster).
• Web-based materials and study website (documents: K2_ICONICplus_Recruitment_Mat_website, mock-up website).
• Recruitment arrangements document (K1__ICONICplus_Recruitment Arr) and K1_ICONICplus_List Trial sites to coordinate recruitment across sites.
• Optional use of a study-specific smartphone app / e-diary for follow-up assessments and for consenting patients (document: D4_ICONICplus_PFD_TherapyDesigner_e-diary).

Germany

Earliest CTIS Part Ii Submission Date

14-04-2025

Latest Decision Or Authorization Date

16-05-2025

Processing Time Days

32

Number Of Sites

2

Number Of Participants

150

Primary sponsor

Full Name

Zentralinstitut Fuer Seelische Gesundheit

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany

Third parties

• {"country":"Germany","full_name":"Universitaetsklinikum Heidelberg AöR","duties_or_roles":"14","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Germany","full_name":"Universitaetsklinikum Heidelberg AöR","duties_or_roles":"1,12,5,8","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Germany","full_name":"Universitaetsklinikum Heidelberg AöR","duties_or_roles":"10,6","organisation_type":"Hospital/Clinic/Other health care facility"}