A multisite randomized clinical trial evaluating BP1.3656 vs placebo for alcohol use disorder treatment.

Phase 2

Withdrawn

• Conditions: alcohol use disorder; alcoholism; 10037176

• Registration Number: NL-OMON45553
• Lead Sponsor: Bioprojet Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

1. Male of female with moderate or severe DSM-5 alcohol use disorder (based on the alcohol use disorders section of the MINI plus);
2. Ages 18-65;
3. Low to moderate alcohol withdrawal symptoms: CIWA-Ar scale < 10 at baseline assessment;
4. Normal weight: 18 kg/m2 * 35 kg/m2;
5. Excessive alcohol use: number of heavy drinking days (* 60g/day in men and * 40 g/day in women) * 15 during 30 days prior to screening and * 7 during the 2 weeks between screening and baseline;
6. Treatment-seeking, treatment goal: reduced drinking or abstinence;
7. If fertile, both males and females must agree to use effective birth control, agree to continue this method for the duration of the study up until 21 days after study completion and be negative to serum pregnancy test performs at the screening visit. Females should not be breastfeeding.;
8. Adequate social support according to the investigator to comply with the study requirements described in the protocol (e.g. transportation to and from the trial site, self-rating scales, drug compliance, scheduled visits, etc.);
9. Voluntarily expressed willingness to participate in the study, understanding protocol procedues and having signed and dated an informed consent prior to the start of the protocol required procedures while not intoxicated (BAC < 0.05);
10. Willingness to receive psychosocial support.

Exclusion Criteria

1. History of delirium tremens, epilepsy, or withdrawal seizures;
2. Clinical depression or suicidality; Beck Depression Inventory (BDI) * 16 and suicidality (item G * 0);
3. Recent illicit drug use, i.e. cannabis, cocaine, amphetamine or opiods;
4. Clinically significant cardiovascular, hematologic, severe hepatic impairment or (FLTs > 3 ULN), renal (stage 2 and 3 according to international classification of renal kidney disease), neurological, endocrinological abnormalities or abnormal clinical laboratory results (in most cases > 3 ULN)
5. History of serious head trauma or injury causing loss of consciousness that lasted more than 3 minutes;
6. HIV positive; HCV postive; HBsAg postive;
7. History of psychosis, or current severe psychiatric disorder, e.g. schizophrenia, bipolar disorder, severe depression or organic brain syndrome unrelated to alcohol abuse;
8. Physical dependence on sedatives or hypnotics that requires pharmacologically supported detox;
9. Receiving ongoing alcohol use disorder medication (e.g. Baclofen);
10. Other active clinically significant illness, which could interfere with the study conduct or counter-indicate the study treatments or place the patient at risk during the trial or compromise the study participation, such as Parkinson*s disease;
11. Known history of syncope, arrhytmia, myocardial infarction or any known significant ECG abnormality;
12. Known hypersensitivity to the tested treatment including active substance and excipients;
13. Participation in clinical trials and receipt of investigational drug(s) during previous 60 days, except as explicitly approve by the principal investigator;
14. Insufficient medical insurance according to local regulations;
15. Pregnant woman or a pregnancy detected with a positive serum pregnancy test performed at the screening visit or lactating women;
16. Male subject who want to conceive a child during the duration of the study up until 21 days after study completion.

Study & Design

• Study Type: Interventional
• Study Design: Not specified