Alcohol Use Disorder
Conditions
Interventions
Trade Name: Champix
Product Name: Champix
Pharmaceutical Form: Capsule
INN or Proposed INN: varenicline
CAS Number: 375815-87-5
Sponsors
Sahlgrenska University Hospital/VGR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria 1) Signed informed consent 2) Blood alcohol level below =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: To assess the effects of the smoking-cessation drugs varenicline and bupropion in combination and alone for reducing alcohol consumption in individuals with AUD. Two primary efficacy end-points will be used. 1) Alcohol consumption as measured by the objective alcohol marker B-PEth 2) Alcohol consumption as measured by heavy drinking days (HDD*) by using the Time Line Follow Back (TLFB) procedure *HDD is defined as =60 grams ethanol for men and =40 grams ethanol for women. The baseline proportion of heavy drinking days is obtained at the screening visit. ; Secondary Objective: Secondary objectives: 1)To assess the effects of the smoking-cessation drugs varenicline and bupropion in combination and alone for reducing alcohol consumption in individuals with AUD by using -The alcohol marker carbohydrate deficient transferrin -The alcohol marker gamma glutamyltransferase -Temporal experience of pleasure scale -OPATUS®CPTA test -Self-reported alcohol consumption by using the TLFB procedure and measured by: -Mean grams alcohol per day -Number of drinking days, drinks per drinking days and abstaining days 2) To assess the effects of varenicline and bupropion in combination and alone on other clinical relevant efficacy endpoints: -Total score of Alcohol Use Identification Test -Alcohol craving measured by Visual analogue scale -Nicotine use measured by nicotine saliva marker cotinine 3)To assess the relationships beteen the above described outcome measures and and plasma drug IMP concentrations measured at visit 4 and 6 ; Primary end point(s): Two primary efficacy end-points will be used. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: A. Will be collected at each study visit, 9 in total. B. Will be collected at baseline and at end of treatment ; Secondary end point(s): 1)To assess the effects of varenicline and bupropion in combination and alone for reducing alcohol consumption in individuals with AUD by using •The indirect alcohol marker carbohydrate deficient transferrin (CDT) •The indirect alcohol marker gamma glutamyltransferase (GGT) •Self-reported alcohol consumption as measured by TLFB: oMean grams of alcohol per day oNumber of drinking days oNumber of drinks per drinking days oNumber of abstaining days 2)Total score of Alcohol Use Identification Test (AUDIT) 3)Alcohol craving as measured by a Visual Analogue Scale (VAS) 4)Nicotine use measured by the nicotine saliva marker cotinine 5)Temporal Experience of Pleasure Scale (TEPS) 6)The Continous Performance Test + Activity test (CPTA) 7)To assess the relationships beteen the above described outcome measures and plasma drug concentrations of bupropion and varenicline measured at visits 4 + 6 | — |
Countries
Sweden
Contacts
Public ContactHelga Lidö, Clinical Trial Manager
Sahlgrenska University Hospital
Outcome results
None listed