Trial · NCT04167306
Varenicline and Bupropion for Alcohol Use Disorder
NCT04167306, Phase 2, Completed, Vastra Gotaland Region; results first posted 2024-06-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Varenicline and Bupropion for Alcohol Use Disorder. Trials, record NCT04167306. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04167306
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Varenicline and Bupropion for Alcohol Use Disorder
- NCT number
- NCT04167306
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 388 participants, actual
- Lead sponsor
- Vastra Gotaland Region
- Conditions
- Alcohol Use Disorder, Alcoholism, Alcohol Dependence
- Interventions
- Varenicline Tartrate 1 mg b.i.d, Bupropion Hydrochloride 150 mg b.i.d, Placebo for varenicline, Placebo for bupropion
- First posted
- 2019-11-18
- Last updated
- 2024-06-07
- Other registries' IDs
- eudract:2018-000048-24
- Results first posted
- 2024-06-07
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Alcohol Consumption as Measured by Phosphatidylethanol (PEth) in Blood | 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. |
| Primary | Alcohol Consumption as Measured by Heavy Drinking Days (HDD) | 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 |
| Secondary | CDT | CDT is calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value) | The indirect alcohol marker carbohydrate deficient transferrin |
| Secondary | GGT | GGT calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value) | The indirect alcohol marker gamma glutamyl transferase |
| Secondary | Self-reported Alcohol Consumption Measured by Time-lime-follow-back | CDT is calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value) | Mean grams of alcohol per day * Number of drinking days * Number of drinks per drinking days * Number of abstaining days |
| Secondary | Alcohol Use Identification Test | Mean difference between total score obtained at baseline and visit 1 | Total score of Alcohol Use Identification Test |
| Secondary | Self-reported Alcohol Craving | 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) | Alcohol craving as measured by a Visual Analogue Scale (VAS) |
| Secondary | Nicotine Use | 77 day-interval. Mean difference between cotinine concentration assessed at Day o and Day 77 | Nicotine use measured by the nicotine saliva marker cotinine in saliva |
| Secondary | The Temporal Experience of Pleasure Scale (TEPS) | 77 day-interval. Mean difference between total scale score assessed at Day 0 and Day 77 | 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. |
| Secondary | The Continous Performance Test + Activity Test | 77 day-interval. Mean difference between outcome measure assessed at Day o and Day 7. | A neuropsychiatric tool addressing inattention, impulsivity and activity |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Alcohol Consumption as Measured by Phosphatidylethanol (PEth) in Blood | PEth is calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value) | modified ITT (mITT), defined as participants taken at least one dose of study drug and documented at least one data entry | mikromol/litre | MEAN |
| PRIMARY | Alcohol Consumption as Measured by Heavy Drinking Days (HDD) | 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. | modified ITT (mITT), defined as subjects taken at least one dose of study drug and documented at least one data entry. | proportion | MEAN |
| SECONDARY | CDT | CDT is calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value) | |||
| SECONDARY | GGT | GGT calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value) | |||
| SECONDARY | Self-reported Alcohol Consumption Measured by Time-lime-follow-back | CDT is calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value) | |||
| SECONDARY | Alcohol Use Identification Test | Mean difference between total score obtained at baseline and visit 1 | |||
| SECONDARY | Self-reported Alcohol Craving | 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) | |||
| SECONDARY | Nicotine Use | 77 day-interval. Mean difference between cotinine concentration assessed at Day o and Day 77 | |||
| SECONDARY | The Temporal Experience of Pleasure Scale (TEPS) | 77 day-interval. Mean difference between total scale score assessed at Day 0 and Day 77 | |||
| SECONDARY | The Continous Performance Test + Activity Test | 77 day-interval. Mean difference between outcome measure assessed at Day o and Day 7. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Alcohol Consumption as Measured by Phosphatidylethanol (PEth) in Blood | 2) Varenicline + Placebo for Bupropion | -0.406 | Standard Error 0.057 | mikromol/litre | |
| Alcohol Consumption as Measured by Phosphatidylethanol (PEth) in Blood | 1) Varenicline + Bupropion | -0.417 | Standard Error 0.041 | mikromol/litre | |
| Alcohol Consumption as Measured by Phosphatidylethanol (PEth) in Blood | 3) Bupropion + Placebo for Varenicline | -0.315 | Standard Error 0.054 | mikromol/litre | |
| Alcohol Consumption as Measured by Phosphatidylethanol (PEth) in Blood | 4) Placebo for Varenicline + Placebo for Bupropion | 0.250 | Standard Error 0.044 | mikromol/litre | |
| Alcohol Consumption as Measured by Heavy Drinking Days (HDD) | 2) Varenicline + Placebo for Bupropion | -0.322 | Standard Error 0.028 | proportion | |
| Alcohol Consumption as Measured by Heavy Drinking Days (HDD) | 1) Varenicline + Bupropion | -0.314 | Standard Error 0.031 | proportion | |
| Alcohol Consumption as Measured by Heavy Drinking Days (HDD) | 3) Bupropion + Placebo for Varenicline | -0.298 | Standard Error 0.035 | proportion | |
| Alcohol Consumption as Measured by Heavy Drinking Days (HDD) | 4) Placebo for Varenicline + Placebo for Bupropion | -0.217 | Standard Error 0.031 | proportion |
Source ClinicalTrials.gov
Participant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 2) Varenicline + Placebo for Bupropion | 97 | |
| Overall Study | STARTED | 1) Varenicline + Bupropion | 101 | |
| Overall Study | STARTED | 3) Bupropion + Placebo for Varenicline | 93 | |
| Overall Study | STARTED | 4) Placebo for Varenicline + Placebo for Bupropion | 97 | |
| Overall Study | Correct Randomized , Received IMP | 2) Varenicline + Placebo for Bupropion | 96 | |
| Overall Study | Correct Randomized , Received IMP | 1) Varenicline + Bupropion | 100 | |
| Overall Study | Correct Randomized , Received IMP | 3) Bupropion + Placebo for Varenicline | 91 | |
| Overall Study | Correct Randomized , Received IMP | 4) Placebo for Varenicline + Placebo for Bupropion | 97 | |
| Overall Study | COMPLETED | 2) Varenicline + Placebo for Bupropion | 76 | |
| Overall Study | COMPLETED | 1) Varenicline + Bupropion | 73 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events116
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | anxiety | Psychiatric disorders | 2) Varenicline + Placebo for Bupropion | 9 | 96 | 9 |
| other | anxiety | Psychiatric disorders | 1) Varenicline + Bupropion | 9 | 101 | 9 |
| other | anxiety | Psychiatric disorders | 3) Bupropion + Placebo for Varenicline | 7 | 91 | 7 |
| other | anxiety | Psychiatric disorders | 4) Placebo for Varenicline + Placebo for Bupropion | 2 | 97 | 2 |
| other | arthralgia | Musculoskeletal and connective tissue disorders | 2) Varenicline + Placebo for Bupropion | 3 | 96 | 3 |
| other | arthralgia | Musculoskeletal and connective tissue disorders | 1) Varenicline + Bupropion | 4 | 101 | 4 |
| other | arthralgia | Musculoskeletal and connective tissue disorders | 3) Bupropion + Placebo for Varenicline | 7 | 91 | 7 |
| other | arthralgia | Musculoskeletal and connective tissue disorders | 4) Placebo for Varenicline + Placebo for Bupropion | 7 | 97 | 7 |
| other | back pain | Musculoskeletal and connective tissue disorders | 2) Varenicline + Placebo for Bupropion | 6 | 96 | 6 |
| other | back pain | Musculoskeletal and connective tissue disorders | 1) Varenicline + Bupropion | 1 | 101 | 1 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 2) Varenicline + Placebo for Bupropion | 0 | 96 |
| Total, all-cause mortality | 1) Varenicline + Bupropion | 0 | 100 |
| Total, all-cause mortality | 3) Bupropion + Placebo for Varenicline | 0 | 91 |
| Total, all-cause mortality | 4) Placebo for Varenicline + Placebo for Bupropion | 0 | 97 |
| Total, other adverse events | 2) Varenicline + Placebo for Bupropion | 92 | 96 |
| Total, other adverse events | 1) Varenicline + Bupropion | 98 | 101 |
| Total, other adverse events | 3) Bupropion + Placebo for Varenicline | 82 | 91 |
| Total, other adverse events | 4) Placebo for Varenicline + Placebo for Bupropion | 84 | 97 |
| Total, serious adverse events | 2) Varenicline + Placebo for Bupropion | 3 | 96 |
| Total, serious adverse events | 1) Varenicline + Bupropion | 2 | 100 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
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