A STUDY OF THE EFFECT OF VARENICLINE AND BUPROPION, IN COMBINATION AND ALONE, FOR THE TREATMENT OF ALCOHOL USE DISORDER
- Conditions
- Alcohol Use DisorderTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2018-000048-24-SE
- Lead Sponsor
- Sahlgrenska University Hospital/VGR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 380
Inclusion criteria
1) Signed informed consent
2) Blood alcohol level below <0.1‰ (0.1 g/L) at signing informed consent
3) 25-70 years of age at screening
4) Moderate and severe AUD according to DSM-V (meeting =4 out of 11 criteria)
5) B-PEth levels of =0.5 µmol/L at screening visit (visit 1)
6) Continuous high alcohol consumption over the last 3 months prior to screening as defined by at least 2 HDD per week on a typical week.
7) Available phone number for contact
8) Ability to speak and write in Swedish
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 320
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
1) Total abstinence between screening and randomization visit
2) Treatment of alcohol withdrawal within 30 days of study initiation
3) Pharmacological treatment within 3 months of study initiation and during the study period that may affect alcohol consumption, including but not exclusive to, varenicline, bupropion, disulfiram, acamprosate, naltrexone, nalmefene, baclofen, topiramate, ondansetron, mirtazapine, methylphenidate, dexamphetamine, atomoxetine, pregabalin, buprenorphine and methadone
4) Non-pharmacological treatment within 3 months of study initiation and during the study
period that may affect alcohol consumption
5) Current continuous use of antidepressants, opioid analgesics, benzodiazepines, zopiclone, zolpidem, hydroxizin, alimemazin, propiomazin, or other sedatives. (The sporadic use of these compounds is accepted.)
6) Any concurrent medication that may affect the results of the trial or is considered to
compromise the safety of the participants in the trial. (See SmPCs for possible interactions.)
7) Laboratory hepatic values of >3 times the upper limit of the normal range, creatinine clearence <30 ml/min, or other clinically significant abnormalities in the screening laboratory values
8) Blood pressure =180/110 at screening
9) Pregnancy, breast-feeding and for premenopausal women, not using one of the contraceptive methods oral contraceptive, intrauterine contraceptive device (copper or hormonal) or subcutaneous inplant.
10) Diabetes mellitus type 1 and diabetes mellitus type 2 in need of insulin treatment
11) Any current psychiatric or somatic disorder or condition that may affect assessments or compromise participant’s safety during the trial
12) ASRS- v1.1, part A score =4 in the marked cut-off section
13) MADRS score = 20
14) Current depression that is not mild (mild depression is accepted)
15) Suicidality
16) Current illicit drug use based on urine-toxicity test and DUDIT
17) History of delirium tremens or abstinence-induced seizures within 5 years of study initiation
18) Epilepsia or seizures other than alcohol-induced, lifetime
19) Severe sleep disturbances
20) Need of alcohol detoxification
21) Living conditions not appropriate to fulfill study requirements
22) Use of herbal drugs/tea and supplementations possibly affecting outcome or safety
23) Previous randomization in this trial or participation in another trial within 3 months of enrolment into this trial.
24) Additional factors that render the participant unable to complete the study, as judged by the investigator
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method