Alcohol Use DisorderPhase 2NCT04167306
Varenicline and Bupropion for Alcohol Use Disorder
A Phase 2 study testing Varenicline Tartrate 1 mg b.i.d and Bupropion Hydrochloride 150 mg b.i.d in people with Alcohol Use Disorder and Alcoholism, run by Vastra Gotaland Region at 4 sites in Sweden.
Trial summary
The COMB study is a randomized double-blind placebo-controlled multicenter trial in Sweden on the efficacy of varenicline and bupropion, in combination and alone, for treatment of alcohol use disorder (AUD). Study design overview: A 13-weeks (91 days) multicenter clinical trial with four parallel groups. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder, Alcoholism, Alcohol Dependence
- What is being tested?
- Varenicline Tartrate 1 mg b.i.d and Bupropion Hydrochloride 150 mg b.i.d
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 388 participants
- Where
- 4 sitesSweden
- Study dates
- 4 Mar 2019to 15 Dec 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Blood alcohol level below <0.1‰ (0.1 g/L) at signing informed consent
- 25-70 years of age at screening
- Moderate and severe AUD according to DSM-V (meeting ≥4 out of 11 criteria)
- B-PEth levels of ≥0.5 µmol/L at screening visit (visit 1)
- 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
- Available phone number for contact
- Ability to speak and write in Swedish
Who cannot join
- Total abstinence between screening and randomization visit
- Treatment of alcohol withdrawal within 30 days of study initiation
- 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
- Non-pharmacological treatment within 3 months of study initiation and during the study period that may affect alcohol consumption
- Current continuous use of antidepressants, opioid analgesics, benzodiazepines, zopiclone, zolpidem, hydroxyzine, alimemazine, propiomazine, or other sedatives. (The sporadic use of these compounds is accepted.)
- 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.)
Show all 24Show fewer
- Laboratory hepatic values of >3 times the upper limit of the normal range, creatinine clearance <30 ml/min, or other clinically significant abnormalities in the screening laboratory values
- Blood pressure ≥180/110 at screening
- 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.
- Diabetes mellitus type 1 and diabetes mellitus type 2 in need of insulin treatment
- Any current psychiatric or somatic disorder or condition that may affect assessments or compromise participant's safety during the trial
- ASRS- v1.1, part A score ≥4 in the marked cut-off section
- MADRS score ≥ 20
- Current depression that is not mild (mild depression is accepted)
- Suicidality
- Current illicit drug use based on urine-toxicity test and DUDIT
- History of delirium tremens or abstinence-induced seizures within 5 years of study initiation
- Epilepsy or seizures other than alcohol-induced, lifetime
- Severe sleep disturbances
- Need of alcohol detoxification
- Living conditions not appropriate to fulfil study requirements
- Use of herbal drugs/tea and supplementations possibly affecting outcome or safety
- Previous randomization in this trial or participation in another trial within 3 months of enrollment into this trial.
- Additional factors that render the participant unable to complete the study, as judged by the investigator
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Beroendekliniken, Sahlgrenska University Hospital, Västra Götalandsregionen
Gothenburg
Linköping University Hospital
Linköping, Region Östergötland
Beroendecentrum Malmö
Malmö, Region Skåne
Stockholm Centre for Dependency Disorders,
Stockholm, Stockholms Läns Sjukvårdområde
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Multicenter Trial on the Efficacy of Varenicline and Bupropion in Combination and Alone, for Treatment of Alcohol Use Disorder
The COMB study is a randomized double-blind placebo-controlled multicenter trial in Sweden on the efficacy of varenicline and bupropion, in combination and alone, for treatment of alcohol use disorder (AUD).
Study design overview: A 13-weeks (91 days) multicenter clinical trial with four parallel groups. 95 subjects per treatment arm will be randomized into the study. 380 subjects with AUD will be randomized in total.
Read the detailed description
Varenicline (Champix®) and bupropion (Zyban®, patent time expired) are approved and marketed in Europe and US for smoking cessation in nicotine use disorder, and for treatment of major depression (bupropion). There is clinical evidence of an additive effect of the drug combination of varenicline and bupropion on smoking cessation. Varenicline has been shown in two RCTs to reduce also alcohol intake in subjects with AUD. It is hypothesized that bupropion will enhance the effect of varenicline and that the combined effect size will be greater than that of approved therapies for AUD. As efficacy endpoint, the trial uses the alcohol specific biomarker for alcohol intake, phosphatidylethanol in blood (B-PEth). Outcome will also be measured by self-reported alcohol consumption, the standard effect measure in AUD trials.This will be the first trial using the biomarker B-PEth as primary outcome variable. The use of a specific objective marker is expected to increase chances for detecting treatment effects.
Development phase: II Number of randomized subjects: 380 subjects with AUD. 95 subjects per treatment arm will be randomized into the study.
Number of sites: Approximately 5 study sites in Sweden
Investigational medicinal products, dosages and administration:
There will be two separate study kits for IMP 1 and IMP 2
Investigational medicinal product 1 (IMP1): Varenicline 1 mg x 2 p.o. daily. The pharmaceutical formulation will be encapsulated tablets for oral use. Varenicline will be escalated from 0.5 to 2 mg daily during the first week.
Investigational medicinal product 2 (IMP 2): Bupropion SR 150 mg x 2 p.o. daily. The pharmaceutical formulation will be encapsulated sustained release (SR) tablets for oral use. Bupropion will be escalated from 150 to 300 mg daily during the first week.
IMP 1 and IMP 2 are distributed at 7 occasions: Day 0, Day 7, Day 21, Day 35, Day 49, Day 63 and Day 77. The doses and route of administration for varenicline and bupropion are those approved and recommended as oral formulations for smoking cessation.
The trial comprises 9 study visits over 91 days: Screening visit,Day 0, Day 7, Day 21, Day 35, Day 49, Day 63, Day 77 and Day 91. Randomization is carried out according to block randomization and eligible subjects are randomized to one of the below described intervention arms.
The study will be performed in accordance with the study protocol, with the latest version of the Declaration of Helsinki, in accordance with GCP principles (ICH-GCP E6-R2), and applicable regulatory requirements in Sweden . The study is approved by competent authority (the Swedish Medical Product Agency) and the Etics committee. The trial is monitored by an independent monitor according to GCP principles.
- Conditions
- Alcohol Use Disorder, Alcoholism, Alcohol Dependence
- Being tested
- Varenicline Tartrate 1 mg b.i.d, Bupropion Hydrochloride 150 mg b.i.d, Placebo for varenicline, Placebo for bupropion
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varenicline Tartrate 1 mg b.i.dDrug
Also called Champix
Capsules for oral use
Bupropion Hydrochloride 150 mg b.i.dDrug
Also called Bupropion Sandoz
Capsules for oral use
Placebo for vareniclineOther
Capsules for oral use
Placebo for bupropionOther
Capsules for oral use
| Study group | Role | What they receive |
|---|---|---|
| 1) Varenicline + Bupropion | Experimental | Investigational medicinal product (IMP) 1: Varenicline 0.5 mg and 1.0 mg and Investigational medicinal product (IMP) 2: Bupropion SR 150 mg Receives: Drug: Varenicline Tartrate 1 mg b.i.d; Drug: Bupropion Hydrochloride 150 mg b.i.d |
| 2) Varenicline + Placebo for Bupropion | Experimental | Investigational medicinal product (IMP) 1: Varenicline 0.5 mg and 1.0 mg and Placebo capsule for IMP 2 (bupropion) Receives: Drug: Varenicline Tartrate 1 mg b.i.d; Other: Placebo for bupropion |
| 3) Bupropion + Placebo for Varenicline | Experimental | Investigational medicinal product (IMP) 2: Bupropion SR 150 mg and Placebo capsule for IMP 1 (varenicline) Receives: Drug: Bupropion Hydrochloride 150 mg b.i.d; Other: Placebo for varenicline |
| 4) Placebo for Varenicline + Placebo for Bupropion | Placebo comparator | Placebo capsule for IMP 1 (varenicline) and Placebo capsule for IMP 2 (bupropion) Receives: Other: Placebo for varenicline; Other: Placebo for bupropion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Consumption as Measured by Phosphatidylethanol (PEth) in Blood
B-PEth: Objective marker for alcohol consumption measured in blood, measured at every study visit. Analysed as mean reduction of PEth per treatment arm, mITT.
Measured: PEth is calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value)
Alcohol Consumption as Measured by Heavy Drinking Days (HDD)
HDD is obtained by the time Line Follow Back procedure, defined as ≥70 grams for men and ≥56 grams for women according to FDA's guidelines. Analysed as mean reduction in HDD share per treatment arm, for mITT
Measured: Number of HDD by 14 days is defined as a mean over the 8-week steady state active treatment period (Day 21-Day77) . ( D21-D77)/4 in order to get a 14 day-period measurment.
Secondary outcomes (10)
CDT
The indirect alcohol marker carbohydrate deficient transferrin
Measured: CDT is calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value)
GGT
The indirect alcohol marker gamma glutamyl transferase
Measured: GGT calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value)
Self-reported Alcohol Consumption Measured by Time-lime-follow-back
Mean grams of alcohol per day
- Number of drinking days
- Number of drinks per drinking days
- Number of abstaining days
Measured: CDT is calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value)
Alcohol Use Identification Test
Total score of Alcohol Use Identification Test
Measured: Mean difference between total score obtained at baseline and visit 1
Self-reported Alcohol Craving
Alcohol craving as measured by a Visual Analogue Scale (VAS)
Measured: Scale range: 0-100 mm. Minimum value: 0 = No craving. Maxumum value: 100 Maximum= Very strong craving. Craving is calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value)
Nicotine Use
Nicotine use measured by the nicotine saliva marker cotinine in saliva
Measured: 77 day-interval. Mean difference between cotinine concentration assessed at Day o and Day 77
The Temporal Experience of Pleasure Scale (TEPS)
A 17-item scale with anticipatory and consummatory components of the experience of pleasure. The scale is used as a proxy to assess a hypodopaminergic state. Worse Outcome: A lower score indicates low experience of pleasure (=proxy for hypodopaminergic state). Better outcome:A high score indicates high experience of pleasure.
Measured: 77 day-interval. Mean difference between total scale score assessed at Day 0 and Day 77
The Continous Performance Test + Activity Test
A neuropsychiatric tool addressing inattention, impulsivity and activity
Measured: 77 day-interval. Mean difference between outcome measure assessed at Day o and Day 7.
Plasma Concentration of Varenicline (ng/ml)
Mean concentration of values obtained at visit 4 and visit 6
Measured: 14 day-interval. Obtained twice, at Day 21 and Day 49 during IMP steady state. Correlation between plasma concentration of varenicline and above described outcome measures
Plasma Concentration of Bupropion (ng/ml)
Mean concentration of values obtained at visit 4 and visit 6
Measured: 14 day-interval. Obtained twice, at Day 21 and Day 49 during IMP steady state. Correlation between plasma concentration of bupropion and above described outcome measures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start4 Mar 2019
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Bo Söderpalm, Prof, MD, Principal investigator, Sahlgrenska University Hospital, Västra Götaland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167306
- Sponsor's protocol ID
- COMB-BO8
- Other IDs
- 2018-000048-24, 2018
- Status last verified
- Dec 2023
- First submitted
- 30 Sep 2019
- Last updated
- 7 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Soderpalm B, Lido H, Franck J, Hakansson A, Lindqvist D, Heilig M, Guterstam J, Samuelson M, Askerup B, Wallmark-Nilsson C, de Bejczy A. Efficacy and safety of varenicline and bupropion, in combination and alone, for alcohol use disorder: a randomized, double-blind, placebo-controlled multicentre trial. Lancet Reg Health Eur. 2025 May 13;54:101310. doi: 10.1016/j.lanepe.2025.101310. eCollection 2025 Jul.
PubMed 40487775de Bejczy A, Lido H, Soderpalm B. A randomized, double-blind, placebo-controlled, multicentre trial on the efficacy of varenicline and bupropion in combination and alone for treatment of alcohol use disorder: Protocol for the COMB study. PLoS One. 2024 Jan 11;19(1):e0296118. doi: 10.1371/journal.pone.0296118. eCollection 2024.
PubMed 38206930
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Multicenter Trial on the Efficacy of Varenicline and Bupropion in Combination and Alone, for Treatment of Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT04167306
- Acronym / sponsor ID
- COMB-BO8
- Conditions
- Alcohol Use Disorder, Alcoholism, Alcohol Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 18 Nov 2019 (actual)
- Results
- Posted 7 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The COMB study is a randomized double-blind placebo-controlled multicenter trial in Sweden on the efficacy of varenicline and bupropion, in combination and alone, for treatment of alcohol use disorder (AUD).
Study design overview: A 13-weeks (91 days) multicenter clinical trial with four parallel groups. 95 subjects per treatment arm will be randomized into the study. 380 subjects with AUD will be randomized in total.
Detailed description
Varenicline (Champix®) and bupropion (Zyban®, patent time expired) are approved and marketed in Europe and US for smoking cessation in nicotine use disorder, and for treatment of major depression (bupropion). There is clinical evidence of an additive effect of the drug combination of varenicline and bupropion on smoking cessation. Varenicline has been shown in two RCTs to reduce also alcohol intake in subjects with AUD. It is hypothesized that bupropion will enhance the effect of varenicline and that the combined effect size will be greater than that of approved therapies for AUD. As efficacy endpoint, the trial uses the alcohol specific biomarker for alcohol intake, phosphatidylethanol in blood (B-PEth). Outcome will also be measured by self-reported alcohol consumption, the standard effect measure in AUD trials.This will be the first trial using the biomarker B-PEth as primary outcome variable. The use of a specific objective marker is expected to increase chances for detecting treatment effects.
Development phase: II Number of randomized subjects: 380 subjects with AUD. 95 subjects per treatment arm will be randomized into the study.
Number of sites: Approximately 5 study sites in Sweden
Investigational medicinal products, dosages and administration:
There will be two separate study kits for IMP 1 and IMP 2
Investigational medicinal product 1 (IMP1): Varenicline 1 mg x 2 p.o. daily. The pharmaceutical formulation will be encapsulated tablets for oral use. Varenicline will be escalated from 0.5 to 2 mg daily during the first week.
Investigational medicinal product 2 (IMP 2): Bupropion SR 150 mg x 2 p.o. daily. The pharmaceutical formulation will be encapsulated sustained release (SR) tablets for oral use. Bupropion will be escalated from 150 to 300 mg daily during the first week.
IMP 1 and IMP 2 are distributed at 7 occasions: Day 0, Day 7, Day 21, Day 35, Day 49, Day 63 and Day 77. The doses and route of administration for varenicline and bupropion are those approved and recommended as oral formulations for smoking cessation.
The trial comprises 9 study visits over 91 days: Screening visit,Day 0, Day 7, Day 21, Day 35, Day 49, Day 63, Day 77 and Day 91. Randomization is carried out according to block randomization and eligible subjects are randomized to one of the below described intervention arms.
The study will be performed in accordance with the study protocol, with the latest version of the Declaration of Helsinki, in accordance with GCP principles (ICH-GCP E6-R2), and applicable regulatory requirements in Sweden . The study is approved by competent authority (the Swedish Medical Product Agency) and the Etics committee. The trial is monitored by an independent monitor according to GCP principles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1) Varenicline + Bupropion | Experimental | Drug: Varenicline Tartrate 1 mg b.i.d, Drug: Bupropion Hydrochloride 150 mg b.i.dInvestigational medicinal product (IMP) 1: Varenicline 0.5 mg and 1.0 mg and Investigational medicinal product (IMP) 2: Bupropion SR 150 mg |
| 2) Varenicline + Placebo for Bupropion | Experimental | Drug: Varenicline Tartrate 1 mg b.i.d, Other: Placebo for bupropionInvestigational medicinal product (IMP) 1: Varenicline 0.5 mg and 1.0 mg and Placebo capsule for IMP 2 (bupropion) |
| 3) Bupropion + Placebo for Varenicline | Experimental | Drug: Bupropion Hydrochloride 150 mg b.i.d, Other: Placebo for vareniclineInvestigational medicinal product (IMP) 2: Bupropion SR 150 mg and Placebo capsule for IMP 1 (varenicline) |
| 4) Placebo for Varenicline + Placebo for Bupropion | Placebo comparator | Other: Placebo for varenicline, Other: Placebo for bupropionPlacebo capsule for IMP 1 (varenicline) and Placebo capsule for IMP 2 (bupropion) |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent
- Blood alcohol level below <0.1‰ (0.1 g/L) at signing informed consent
- 25-70 years of age at screening
- Moderate and severe AUD according to DSM-V (meeting ≥4 out of 11 criteria)
- B-PEth levels of ≥0.5 µmol/L at screening visit (visit 1)
Key exclusion criteria (24 listed)
- Total abstinence between screening and randomization visit
- Treatment of alcohol withdrawal within 30 days of study initiation
- 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
- Non-pharmacological treatment within 3 months of study initiation and during the study period that may affect alcohol consumption
- Current continuous use of antidepressants, opioid analgesics, benzodiazepines, zopiclone, zolpidem, hydroxyzine, alimemazine, propiomazine, or other sedatives. (The sporadic use of these compounds is accepted.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Varenicline Tartrate 1 mg b.i.dAlso: ChampixCapsules for oral use | Drug | 1) Varenicline + Bupropion, 2) Varenicline + Placebo for Bupropion |
| Bupropion Hydrochloride 150 mg b.i.dAlso: Bupropion SandozCapsules for oral use | Drug | 1) Varenicline + Bupropion, 3) Bupropion + Placebo for Varenicline |
| Placebo for vareniclineCapsules for oral use | Other | 3) Bupropion + Placebo for Varenicline, 4) Placebo for Varenicline + Placebo for Bupropion |
| Placebo for bupropionCapsules for oral use | Other | 2) Varenicline + Placebo for Bupropion, 4) Placebo for Varenicline + Placebo for Bupropion |
Primary outcome
Alcohol Consumption as Measured by Phosphatidylethanol (PEth) in Blood
Time frame: PEth is calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value)
B-PEth: Objective marker for alcohol consumption measured in blood, measured at every study visit. Analysed as mean reduction of PEth per treatment arm, mITT.
Alcohol Consumption as Measured by Heavy Drinking Days (HDD)
Time frame: Number of HDD by 14 days is defined as a mean over the 8-week steady state active treatment period (Day 21-Day77) . ( D21-D77)/4 in order to get a 14 day-period measurment.
HDD is obtained by the time Line Follow Back procedure, defined as ≥70 grams for men and ≥56 grams for women according to FDA's guidelines. Analysed as mean reduction in HDD share per treatment arm, for mITT
10 secondary outcomes
CDT
Time frame: CDT is calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value)
GGT
Time frame: GGT calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value)
Self-reported Alcohol Consumption Measured by Time-lime-follow-back
Time frame: CDT is calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value)
Alcohol Use Identification Test
Time frame: Mean difference between total score obtained at baseline and visit 1
Self-reported Alcohol Craving
Time frame: Scale range: 0-100 mm. Minimum value: 0 = No craving. Maxumum value: 100 Maximum= Very strong craving. Craving is calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value)
Nicotine Use
Time frame: 77 day-interval. Mean difference between cotinine concentration assessed at Day o and Day 77
The Temporal Experience of Pleasure Scale (TEPS)
Time frame: 77 day-interval. Mean difference between total scale score assessed at Day 0 and Day 77
The Continous Performance Test + Activity Test
Time frame: 77 day-interval. Mean difference between outcome measure assessed at Day o and Day 7.
Plasma Concentration of Varenicline (ng/ml)
Time frame: 14 day-interval. Obtained twice, at Day 21 and Day 49 during IMP steady state. Correlation between plasma concentration of varenicline and above described outcome measures
Plasma Concentration of Bupropion (ng/ml)
Time frame: 14 day-interval. Obtained twice, at Day 21 and Day 49 during IMP steady state. Correlation between plasma concentration of bupropion and above described outcome measures
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40487775Soderpalm B, Lido H, Franck J, Hakansson A, Lindqvist D, Heilig M, Guterstam J, Samuelson M, Askerup B, Wallmark-Nilsson C, de Bejczy A. Efficacy and safety of varenicline and bupropion, in combination and alone, for alcohol use disorder: a randomized, double-blind, placebo-controlled multicentre trial. Lancet Reg Health Eur. 2025 May 13;54:101310. doi: 10.1016/j.lanepe.2025.101310. eCollection 2025 Jul.
- Derived from this study: PubMed 38206930de Bejczy A, Lido H, Soderpalm B. A randomized, double-blind, placebo-controlled, multicentre trial on the efficacy of varenicline and bupropion in combination and alone for treatment of alcohol use disorder: Protocol for the COMB study. PLoS One. 2024 Jan 11;19(1):e0296118. doi: 10.1371/journal.pone.0296118. eCollection 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Söderpalm, Prof, MD principal investigator
Sahlgrenska University Hospital, Västra Götaland
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Varenicline Tartrate 1 mg b.i.d and Bupropion Hydrochloride 150 mg b.i.d in people with Alcohol Use Disorder and Alcoholism, run by Vastra Gotaland Region at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Consumption as Measured by Phosphatidylethanol (PEth) in Blood (time frame: PEth is calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04167306, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.