INTERVENTIONALRECRUITINGNCT06845124

ICONICplus - Randomized, Double-blind, Placebo-controlled Trial to Investigate the Effects of Cannabidiol Plus Naltrexone on Cue-Induced Alcohol Craving in Alcohol Dependence

Alcohol addiction (AD) is a chronic relapsing disorder with currently limited pharmacological treatment options. Alcohol craving, a hallmark symptom of AD that drives relapse in patients, is only insufficiently treated by existing medication. One promising new compound for the treatment of alcohol craving in AD is Cannabidiol (CBD), which showed beneficial effects on alcohol craving in preliminary clinical studies. Additionally, CBD seems to be a particularly promising candidate for enhancing the effects of established medication, specifically Naltrexone (NTX), an opioid-antagonist, which is approved for AD treatment, due to the synergistic effects of the combination of Cannabidiol plus Naltrexone on alcohol consumption that were shown by preclinical studies. The proposed three-armed, 1:1:1 randomized, double-blind, placebo-controlled parallel group, multicentric phase II trial seeks to test the putative synergistic effects of combined CBD (800mg) + oral NTX (50mg) against CBD (1200mg) + oral NTX (50mg) against Placebo + oral NTX (50mg) on alcohol craving (primary outcome) in male and female patients with AD that suffer from high alcohol craving. The trial seeks to test the effects of the innovative combination of CBD plus NTX against Placebo plus NTX on alcohol craving over a 14-day treatment period, which is embedded in a standardized addiction treatment program according to current treatment guidelines, in order to estimate the added value of treatment with CBD on alcohol craving. Quality of life and neurobiological and biochemical markers for craving will serve as secondary outcomes, because they show strong associations to treatment outcome and relapse risk. Collection and analysis of follow-up data (28 days, 42 days, 105 days, 196 days) will be performed to determine whether treatment effects relate to patient outcome.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-02-03

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE2
Enrollment: 150 (ESTIMATED)
Start date: 2025-07-22
Sponsor: Central Institute of Mental Health, Mannheim
Design: RANDOMIZED · PARALLEL · TREATMENT
Locations: 2
Results record: Not present in registry snapshot

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

Alcoholism

Cannabinoids and active compounds

cannabidiol

Medicines

No exact medicine-name link was found.

Interventions

What was registered

DRUG

Cannabidiol capsules

800mg (trial arm 1) or 1200mg (trial arm 2) Cannabidiol capsules will be administered daily over the course of 14 days.

DRUG

Naltrexone (drug)

All participants will receive 50mg Naltrexone daily as oral tablet throughout the study.

DRUG

Placebo

Placebo capsules matching the cannabidiol capsules will be administered daily.

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Not accepted

secondary measures

Obsessive Compulsive Drinking Scale (OCDS-G)

Time frame: Differences from baseline (visit 2, day -2) of Obsessive Compulsive Drinking Scale craving scores to visits 4 (day 7, i.e., 7 days after the first treatment visit) and during follow up visits 6 (day 28), 7 (day 42), 8 (day 105), 9 (day 196)

The alcohol craving will be assessed at separate time points before and after Cannabidiol administration using the Obsessive Compulsive Drinking Scale. The Obsessive Compulsive Drinking Scale consists of 14 items, each rated on a 5-point Likert scale (0-4), resulting in scores from 0 to 40, with higher scores indicating higher craving.

Subjective quality of life index

Time frame: Differences from baseline (visit 2, day -2) of Quality of life (WHO-QOL-BREF scores) to end of treatment (visit 5, day 14) and follow up visits 6 (day 28), 7 (day 42), 8 (day 105), 9 (day 196).

Quality of life will be assessed using the World Health Organization Quality of life questionnaire (WHO-QOL-BREF) scores at separate time points before and after Cannabidiol administration. The World Health Organization Quality of life questionnaire is an instrument that can assess patients' global health status independently of disease across 4 health domains and consists of 26 items rated on a 5-point Likert scale (1-5). To calculate the score, items 3, 4, 26 have to be inverted. Scores for each domain (Physical Health, Psychological Health, Social Relationships, Environment) are calculated, that range from 4 to 20. Higher scores indicate better quality of life, with the overall score reflecting a person's general well-being.

Beck Depression Inventory (BDI-II)

Time frame: Difference from baseline (visit 2, day -2) of depressive symptoms to end of treatment (visit 5, day 14)

The depressive symptoms will be assessed at separate time points before and after Cannabidiol administration using the Beck Depression Inventory (BDI-II). The Beck Depression Inventory (BDI-II) is a 21-item self-rating inventory that measures characteristic attitudes and symptoms of depression. Each Item is rated on a 4-point Likert scale (0-3). The total score ranges from 0 to 63, with higher scores indicating more severe depressive symptoms.

State Trait Anxiety Inventory (STAI)

Time frame: Difference from baseline (visit 2, day -2) of depressive symptoms to end of treatment (visit 5, day 14)

The state and trait anxiety will be assessed at separate time points before and after Cannabidiol administration using the State Trait Anxiety Inventory. The State Trait Anxiety Inventory (STAI) is a 20-item self-report questionnaire that assesses state anxiety and trait anxiety via two subscales: the State Anxiety Scale (STAI-S) and the Trait Anxiety Scale (STAI-T), each consisting of 20 items. Each item is rated on a 4-point Likert scale (1-4). A sumscore has to be calculated for each subscale, ranging from 20 to 80 each, with higher scores indicating higher levels of anxiety.

Patient reported outcomes (PRO)

Time frame: On visit 3 (day 1 of treatment), visit 4 (day 7 of treatment), visit 5 (day 14, end of treatment) and during follow up visits 6 (day 28), 7 (day 42), 8 (day 105), 9 (day 196)

The patient reported outcomes will be assessed at separate time points before and after Cannabidiol administration using a set of items assessing effects of the treatment as well as treatment burden on a five-point Likert scale (0 to 4) with higher values indicating more positive effects.

CBD plasma levels

Time frame: On visit 3 (day 1 of treatment) and visit 5 (day 14, end of treatment)

The CBD plasma levels will be determined at separate time points before and after Cannabidiol administration to detect effects of active intervention on blood plasma levels. (Only participants enrolled at CIMH study site).

Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: On visit 3 (day 1 of treatment), visit 4 (day 7 of treatment), visit 5 (day 14, end of treatment) and during follow up visits 6 (day 28), 7 (day 42), 8 (day 105), 9 (day 196)

Rate of adverse events and serious adverse events.

Time to relapse

Time frame: On visit 5 (day 14, end of treatment) and during follow up visits 6 (day 28), 7 (day 42), 8 (day 105), 9 (day 196)

Time from baseline (visit 2, day -2) to relapse to alcohol use (i.e. any alcohol use) (in days), assessed using the Form-90 semi-structured interview (Timeline Follow Back).

Cumulative alcohol consumption during the follow-up period

Time frame: On visit 5 (day 14, end of treatment) and during follow up visits 6 (day 28), 7 (day 42), 8 (day 105), 9 (day 196)

Cumulative alcohol consumption (in grams alcohol) during the follow-up period of 182 days (+/- 7 days), assessed using the Form-90 semi-structured interview (Timeline Follow Back).

Percent heavy drinking days during the follow-up period

Time frame: On visit 5 (day 14, end of treatment) and during follow up visits 6 (day 28), 7 (day 42), 8 (day 105), 9 (day 196)

Percent heavy drinking days during the follow-up period of 182 days (+/- 7 days), assessed using the Form-90 semi-structured interview (Timeline Follow Back).

Average weekly alcohol consumption during the follow-up period

Time frame: Every 7 days during the follow-up period of 182 days (+/- 7 days), starting after visit 5, i.e., end of treatment (day 14) and continuing until visit 9, i.e., end of follow up (day 196)

Average weekly alcohol consumption assessed via smartphone-based e-diary every 7 days during the follow-up period of 182 days (+/- 7 days) (optional, only for patients that agree to use the study-specific app).

Maximum weekly craving during the follow-up period

Maximum weekly craving assessed via smartphone-based e-diary every 7 days during the follow-up period of 182 days (+/- 7 days) (optional, only for patients that agree to use the study-specific app).