Trial Outcomes & Findings for Varenicline and Bupropion for Alcohol Use Disorder (NCT NCT04167306)
NCT ID: NCT04167306
Last Updated: 2024-06-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
388 participants
Primary outcome timeframe
PEth is calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value)
Results posted on
2024-06-07
Participant Flow
Participant milestones
| Measure |
2) Varenicline + Placebo for Bupropion
Investigational medicinal product (IMP) 1: Varenicline 0.5 mg and 1.0 mg and Placebo capsule for IMP 2 (bupropion)
Varenicline Tartrate 1 mg b.i.d: Capsules for oral use
Placebo for bupropion: Capsules for oral use
|
1) Varenicline + Bupropion
Investigational medicinal product (IMP) 1: Varenicline 0.5 mg and 1.0 mg and Investigational medicinal product (IMP) 2: Bupropion SR 150 mg
Varenicline Tartrate 1 mg b.i.d: Capsules for oral use
Bupropion Hydrochloride 150 mg b.i.d: Capsules for oral use
|
3) Bupropion + Placebo for Varenicline
Investigational medicinal product (IMP) 2: Bupropion SR 150 mg and Placebo capsule for IMP 1 (varenicline)
Bupropion Hydrochloride 150 mg b.i.d: Capsules for oral use
Placebo for varenicline: Capsules for oral use
|
4) Placebo for Varenicline + Placebo for Bupropion
Placebo capsule for IMP 1 (varenicline) and Placebo capsule for IMP 2 (bupropion)
Placebo for varenicline: Capsules for oral use
Placebo for bupropion: Capsules for oral use
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
97
|
101
|
93
|
97
|
|
Overall Study
Correct Randomized , Received IMP
|
96
|
100
|
91
|
97
|
|
Overall Study
COMPLETED
|
76
|
73
|
67
|
81
|
|
Overall Study
NOT COMPLETED
|
21
|
28
|
26
|
16
|
Reasons for withdrawal
| Measure |
2) Varenicline + Placebo for Bupropion
Investigational medicinal product (IMP) 1: Varenicline 0.5 mg and 1.0 mg and Placebo capsule for IMP 2 (bupropion)
Varenicline Tartrate 1 mg b.i.d: Capsules for oral use
Placebo for bupropion: Capsules for oral use
|
1) Varenicline + Bupropion
Investigational medicinal product (IMP) 1: Varenicline 0.5 mg and 1.0 mg and Investigational medicinal product (IMP) 2: Bupropion SR 150 mg
Varenicline Tartrate 1 mg b.i.d: Capsules for oral use
Bupropion Hydrochloride 150 mg b.i.d: Capsules for oral use
|
3) Bupropion + Placebo for Varenicline
Investigational medicinal product (IMP) 2: Bupropion SR 150 mg and Placebo capsule for IMP 1 (varenicline)
Bupropion Hydrochloride 150 mg b.i.d: Capsules for oral use
Placebo for varenicline: Capsules for oral use
|
4) Placebo for Varenicline + Placebo for Bupropion
Placebo capsule for IMP 1 (varenicline) and Placebo capsule for IMP 2 (bupropion)
Placebo for varenicline: Capsules for oral use
Placebo for bupropion: Capsules for oral use
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
5
|
5
|
|
Overall Study
Adverse Event
|
13
|
14
|
5
|
4
|
|
Overall Study
Withdrawal by Subject
|
4
|
6
|
8
|
3
|
|
Overall Study
covid
|
1
|
1
|
2
|
1
|
|
Overall Study
concomitant medication
|
0
|
0
|
0
|
1
|
|
Overall Study
Alcohol treatment
|
0
|
4
|
3
|
2
|
|
Overall Study
non-compliance
|
0
|
0
|
1
|
0
|
|
Overall Study
incorrectly randomized or did not commence study drug
|
1
|
1
|
2
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
1) Varenicline + Bupropion
n=100 Participants
Investigational medicinal product (IMP) 1: Varenicline 0.5 mg and 1.0 mg and Investigational medicinal product (IMP) 2: Bupropion SR 150 mg
Varenicline Tartrate 1 mg b.i.d: Capsules for oral use
Bupropion Hydrochloride 150 mg b.i.d: Capsules for oral use
|
2) Varenicline + Placebo for Bupropion
n=96 Participants
Investigational medicinal product (IMP) 1: Varenicline 0.5 mg and 1.0 mg and Placebo capsule for IMP 2 (bupropion)
Varenicline Tartrate 1 mg b.i.d: Capsules for oral use
Placebo for bupropion: Capsules for oral use
|
3) Bupropion + Placebo for Varenicline
n=91 Participants
Investigational medicinal product (IMP) 2: Bupropion SR 150 mg and Placebo capsule for IMP 1 (varenicline)
Bupropion Hydrochloride 150 mg b.i.d: Capsules for oral use
Placebo for varenicline: Capsules for oral use
|
4) Placebo for Varenicline + Placebo for Bupropion
n=97 Participants
Placebo capsule for IMP 1 (varenicline) and Placebo capsule for IMP 2 (bupropion)
Placebo for varenicline: Capsules for oral use
Placebo for bupropion: Capsules for oral use
|
Total
n=384 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 8.3 • n=100 Participants
|
56 years
STANDARD_DEVIATION 9.7 • n=96 Participants
|
56 years
STANDARD_DEVIATION 9.2 • n=91 Participants
|
56 years
STANDARD_DEVIATION 9.9 • n=97 Participants
|
56 years
STANDARD_DEVIATION 9.2 • n=384 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=100 Participants
|
27 Participants
n=96 Participants
|
18 Participants
n=91 Participants
|
34 Participants
n=97 Participants
|
107 Participants
n=384 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=100 Participants
|
69 Participants
n=96 Participants
|
73 Participants
n=91 Participants
|
63 Participants
n=97 Participants
|
277 Participants
n=384 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Phosphatidylethanol (B-PEth)
|
1.2 mikromol/L
STANDARD_DEVIATION 0.66 • n=100 Participants
|
1.2 mikromol/L
STANDARD_DEVIATION 0.76 • n=96 Participants
|
1.3 mikromol/L
STANDARD_DEVIATION 0.62 • n=91 Participants
|
1.2 mikromol/L
STANDARD_DEVIATION 0.55 • n=97 Participants
|
1.2 mikromol/L
STANDARD_DEVIATION 0.65 • n=384 Participants
|
|
Heavy Drinking Days (HDD)
|
0.72 proportion
STANDARD_DEVIATION 0.30 • n=100 Participants
|
0.76 proportion
STANDARD_DEVIATION 0.25 • n=96 Participants
|
0.75 proportion
STANDARD_DEVIATION 0.26 • n=91 Participants
|
0.74 proportion
STANDARD_DEVIATION 0.28 • n=97 Participants
|
0.74 proportion
STANDARD_DEVIATION 0.27 • n=384 Participants
|
|
Age at Alcohol debut
|
15 years
STANDARD_DEVIATION 3.0 • n=100 Participants
|
15 years
STANDARD_DEVIATION 4.1 • n=96 Participants
|
15 years
STANDARD_DEVIATION 2.7 • n=91 Participants
|
16 years
STANDARD_DEVIATION 5.3 • n=97 Participants
|
16 years
STANDARD_DEVIATION 3.9 • n=384 Participants
|
|
Heredity for alcohol problems
|
25 Participants
n=100 Participants
|
15 Participants
n=96 Participants
|
17 Participants
n=91 Participants
|
16 Participants
n=97 Participants
|
73 Participants
n=384 Participants
|
PRIMARY outcome
Timeframe: PEth is calculated as the mean value over the active steady state period (Day 21-Day77) compared to baseline (=screening visit value)Population: modified ITT (mITT), defined as participants taken at least one dose of study drug and documented at least one data entry
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.
Outcome measures
| Measure |
2) Varenicline + Placebo for Bupropion
n=96 Participants
Investigational medicinal product (IMP) 1: Varenicline 0.5 mg and 1.0 mg and Placebo capsule for IMP 2 (bupropion)
Varenicline Tartrate 1 mg b.i.d: Capsules for oral use
Placebo for bupropion: Capsules for oral use
|
1) Varenicline + Bupropion
n=100 Participants
Investigational medicinal product (IMP) 1: Varenicline 0.5 mg and 1.0 mg and Investigational medicinal product (IMP) 2: Bupropion SR 150 mg
Varenicline Tartrate 1 mg b.i.d: Capsules for oral use
Bupropion Hydrochloride 150 mg b.i.d: Capsules for oral use
|
3) Bupropion + Placebo for Varenicline
n=91 Participants
Investigational medicinal product (IMP) 2: Bupropion SR 150 mg and Placebo capsule for IMP 1 (varenicline)
Bupropion Hydrochloride 150 mg b.i.d: Capsules for oral use
Placebo for varenicline: Capsules for oral use
|
4) Placebo for Varenicline + Placebo for Bupropion
n=97 Participants
Placebo capsule for IMP 1 (varenicline) and Placebo capsule for IMP 2 (bupropion)
Placebo for varenicline: Capsules for oral use
Placebo for bupropion: Capsules for oral use
|
|---|---|---|---|---|
|
Alcohol Consumption as Measured by Phosphatidylethanol (PEth) in Blood
|
-0.406 mikromol/litre
Standard Error 0.057
|
-0.417 mikromol/litre
Standard Error 0.041
|
-0.315 mikromol/litre
Standard Error 0.054
|
0.250 mikromol/litre
Standard Error 0.044
|
PRIMARY outcome
Timeframe: 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.Population: modified ITT (mITT), defined as subjects taken at least one dose of study drug and documented at least one data entry.
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
Outcome measures
| Measure |
2) Varenicline + Placebo for Bupropion
n=96 Participants
Investigational medicinal product (IMP) 1: Varenicline 0.5 mg and 1.0 mg and Placebo capsule for IMP 2 (bupropion)
Varenicline Tartrate 1 mg b.i.d: Capsules for oral use
Placebo for bupropion: Capsules for oral use
|
1) Varenicline + Bupropion
n=100 Participants
Investigational medicinal product (IMP) 1: Varenicline 0.5 mg and 1.0 mg and Investigational medicinal product (IMP) 2: Bupropion SR 150 mg
Varenicline Tartrate 1 mg b.i.d: Capsules for oral use
Bupropion Hydrochloride 150 mg b.i.d: Capsules for oral use
|
3) Bupropion + Placebo for Varenicline
n=91 Participants
Investigational medicinal product (IMP) 2: Bupropion SR 150 mg and Placebo capsule for IMP 1 (varenicline)
Bupropion Hydrochloride 150 mg b.i.d: Capsules for oral use
Placebo for varenicline: Capsules for oral use
|
4) Placebo for Varenicline + Placebo for Bupropion
n=97 Participants
Placebo capsule for IMP 1 (varenicline) and Placebo capsule for IMP 2 (bupropion)
Placebo for varenicline: Capsules for oral use
Placebo for bupropion: Capsules for oral use
|
|---|---|---|---|---|
|
Alcohol Consumption as Measured by Heavy Drinking Days (HDD)
|
-0.322 proportion
Standard Error 0.028
|
-0.314 proportion
Standard Error 0.031
|
-0.298 proportion
Standard Error 0.035
|
-0.217 proportion
Standard Error 0.031
|
SECONDARY outcome
Timeframe: 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Mean difference between total score obtained at baseline and visit 1Total score of Alcohol Use Identification Test
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 77 day-interval. Mean difference between cotinine concentration assessed at Day o and Day 77Nicotine use measured by the nicotine saliva marker cotinine in saliva
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 77 day-interval. Mean difference between total scale score assessed at Day 0 and Day 77A 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 77 day-interval. Mean difference between outcome measure assessed at Day o and Day 7.A neuropsychiatric tool addressing inattention, impulsivity and activity
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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 measuresMean concentration of values obtained at visit 4 and visit 6
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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 measuresMean concentration of values obtained at visit 4 and visit 6
Outcome measures
Outcome data not reported
Adverse Events
2) Varenicline + Placebo for Bupropion
Serious events: 3 serious events
Other events: 92 other events
Deaths: 0 deaths
1) Varenicline + Bupropion
Serious events: 2 serious events
Other events: 98 other events
Deaths: 0 deaths
3) Bupropion + Placebo for Varenicline
Serious events: 3 serious events
Other events: 82 other events
Deaths: 0 deaths
4) Placebo for Varenicline + Placebo for Bupropion
Serious events: 3 serious events
Other events: 84 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2) Varenicline + Placebo for Bupropion
n=96 participants at risk
Investigational medicinal product (IMP) 1: Varenicline 0.5 mg and 1.0 mg and Placebo capsule for IMP 2 (bupropion)
Varenicline Tartrate 1 mg b.i.d: Capsules for oral use
Placebo for bupropion: Capsules for oral use
|
1) Varenicline + Bupropion
n=101 participants at risk；n=100 participants at risk
Investigational medicinal product (IMP) 1: Varenicline 0.5 mg and 1.0 mg and Investigational medicinal product (IMP) 2: Bupropion SR 150 mg
Varenicline Tartrate 1 mg b.i.d: Capsules for oral use
Bupropion Hydrochloride 150 mg b.i.d: Capsules for oral use
|
3) Bupropion + Placebo for Varenicline
n=91 participants at risk
Investigational medicinal product (IMP) 2: Bupropion SR 150 mg and Placebo capsule for IMP 1 (varenicline)
Bupropion Hydrochloride 150 mg b.i.d: Capsules for oral use
Placebo for varenicline: Capsules for oral use
|
4) Placebo for Varenicline + Placebo for Bupropion
n=97 participants at risk
Placebo capsule for IMP 1 (varenicline) and Placebo capsule for IMP 2 (bupropion)
Placebo for varenicline: Capsules for oral use
Placebo for bupropion: Capsules for oral use
|
|---|---|---|---|---|
|
Cardiac disorders
heart failure
|
0.00%
0/96 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
1.0%
1/100 • Number of events 1 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
0.00%
0/91 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
0.00%
0/97 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/96 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
0.00%
0/100 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
0.00%
0/91 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
1.0%
1/97 • Number of events 1 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
|
Blood and lymphatic system disorders
pulmonary embolism
|
0.00%
0/96 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
1.0%
1/100 • Number of events 1 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
0.00%
0/91 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
0.00%
0/97 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
malignt melanoema of skin
|
0.00%
0/96 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
0.00%
0/100 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
1.1%
1/91 • Number of events 1 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
0.00%
0/97 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
breast cancer
|
0.00%
0/96 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
0.00%
0/100 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
0.00%
0/91 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
1.0%
1/97 • Number of events 1 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
|
Gastrointestinal disorders
abdominal pain upper
|
1.0%
1/96 • Number of events 1 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
0.00%
0/100 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
0.00%
0/91 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
0.00%
0/97 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
|
Cardiac disorders
acute myocardial infarction
|
1.0%
1/96 • Number of events 1 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
0.00%
0/100 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
0.00%
0/91 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
0.00%
0/97 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
prostate cancer
|
0.00%
0/96 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
0.00%
0/100 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
0.00%
0/91 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
1.0%
1/97 • Number of events 1 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
|
Cardiac disorders
tachycardia irregular
|
1.0%
1/96 • Number of events 1 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
0.00%
0/100 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
0.00%
0/91 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
0.00%
0/97 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
|
Gastrointestinal disorders
calculus of gallbladder with acute cholecystitis, with obstruction
|
0.00%
0/96 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
0.00%
0/100 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
1.1%
1/91 • Number of events 1 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
0.00%
0/97 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
Other adverse events
| Measure |
2) Varenicline + Placebo for Bupropion
n=96 participants at risk
Investigational medicinal product (IMP) 1: Varenicline 0.5 mg and 1.0 mg and Placebo capsule for IMP 2 (bupropion)
Varenicline Tartrate 1 mg b.i.d: Capsules for oral use
Placebo for bupropion: Capsules for oral use
|
1) Varenicline + Bupropion
n=101 participants at risk；n=100 participants at risk
Investigational medicinal product (IMP) 1: Varenicline 0.5 mg and 1.0 mg and Investigational medicinal product (IMP) 2: Bupropion SR 150 mg
Varenicline Tartrate 1 mg b.i.d: Capsules for oral use
Bupropion Hydrochloride 150 mg b.i.d: Capsules for oral use
|
3) Bupropion + Placebo for Varenicline
n=91 participants at risk
Investigational medicinal product (IMP) 2: Bupropion SR 150 mg and Placebo capsule for IMP 1 (varenicline)
Bupropion Hydrochloride 150 mg b.i.d: Capsules for oral use
Placebo for varenicline: Capsules for oral use
|
4) Placebo for Varenicline + Placebo for Bupropion
n=97 participants at risk
Placebo capsule for IMP 1 (varenicline) and Placebo capsule for IMP 2 (bupropion)
Placebo for varenicline: Capsules for oral use
Placebo for bupropion: Capsules for oral use
|
|---|---|---|---|---|
|
Psychiatric disorders
anxiety
|
9.4%
9/96 • Number of events 9 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
8.9%
9/101 • Number of events 9 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
7.7%
7/91 • Number of events 7 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
2.1%
2/97 • Number of events 2 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
3.1%
3/96 • Number of events 3 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
4.0%
4/101 • Number of events 4 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
7.7%
7/91 • Number of events 7 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
7.2%
7/97 • Number of events 7 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
|
Musculoskeletal and connective tissue disorders
back pain
|
6.2%
6/96 • Number of events 6 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
0.99%
1/101 • Number of events 1 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
5.5%
5/91 • Number of events 5 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
7.2%
7/97 • Number of events 7 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
|
Cardiac disorders
increased blood pressure
|
6.2%
6/96 • Number of events 6 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
5.9%
6/101 • Number of events 6 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
4.4%
4/91 • Number of events 4 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
7.2%
7/97 • Number of events 7 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
|
Infections and infestations
cough
|
8.3%
8/96 • Number of events 8 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
6.9%
7/101 • Number of events 7 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
6.6%
6/91 • Number of events 6 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
7.2%
7/97 • Number of events 7 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
|
Psychiatric disorders
depressed mood
|
15.6%
15/96 • Number of events 16 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
12.9%
13/101 • Number of events 16 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
14.3%
13/91 • Number of events 16 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
16.5%
16/97 • Number of events 16 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
|
Nervous system disorders
dizziness
|
14.6%
14/96 • Number of events 14 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
5.0%
5/101 • Number of events 5 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
16.5%
15/91 • Number of events 15 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
1.0%
1/97 • Number of events 1 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
|
Gastrointestinal disorders
diarrhea
|
8.3%
8/96 • Number of events 8 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
3.0%
3/101 • Number of events 3 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
4.4%
4/91 • Number of events 4 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
8.2%
8/97 • Number of events 8 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
|
Nervous system disorders
dry mouth
|
5.2%
5/96 • Number of events 5 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
10.9%
11/101 • Number of events 11 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
6.6%
6/91 • Number of events 6 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
4.1%
4/97 • Number of events 4 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
|
Psychiatric disorders
fatigue
|
24.0%
23/96 • Number of events 23 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
8.9%
9/101 • Number of events 9 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
13.2%
12/91 • Number of events 12 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
11.3%
11/97 • Number of events 11 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
|
Nervous system disorders
headache
|
36.5%
35/96 • Number of events 35 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
38.6%
39/101 • Number of events 39 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
29.7%
27/91 • Number of events 27 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
41.2%
40/97 • Number of events 40 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
|
Gastrointestinal disorders
increased hepaic enzymes
|
8.3%
8/96 • Number of events 8 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
3.0%
3/101 • Number of events 3 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
7.7%
7/91 • Number of events 7 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
11.3%
11/97 • Number of events 11 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
|
Psychiatric disorders
insomnia
|
16.7%
16/96 • Number of events 16 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
17.8%
18/101 • Number of events 18 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
16.5%
15/91 • Number of events 15 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
10.3%
10/97 • Number of events 10 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
|
Infections and infestations
nasopharyngitis
|
27.1%
26/96 • Number of events 26 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
26.7%
27/101 • Number of events 27 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
19.8%
18/91 • Number of events 18 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
23.7%
23/97 • Number of events 23 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
|
Gastrointestinal disorders
nausea
|
63.5%
61/96 • Number of events 61 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
37.6%
38/101 • Number of events 38 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
13.2%
12/91 • Number of events 12 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
11.3%
11/97 • Number of events 11 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
|
Infections and infestations
pyrexia
|
3.1%
3/96 • Number of events 3 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
5.9%
6/101 • Number of events 6 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
8.8%
8/91 • Number of events 8 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
3.1%
3/97 • Number of events 3 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
|
Psychiatric disorders
sleep disorder
|
4.2%
4/96 • Number of events 4 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
8.9%
9/101 • Number of events 9 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
2.2%
2/91 • Number of events 2 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
6.2%
6/97 • Number of events 6 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
|
Nervous system disorders
vertigo
|
6.2%
6/96 • Number of events 6 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
7.9%
8/101 • Number of events 8 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
5.5%
5/91 • Number of events 5 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
3.1%
3/97 • Number of events 3 • from inclusion (at informed consent) until last Follow-up at 30 days after study drug termination
safety population is equal to mITT population, subjects receiving at least one dose of study drug, N=384
|
Additional Information
Andrea de Bejczy
Addiction BIology Unit - Clinical Trials, Inst Neuroecience and Physiology, Gotheburg University/ Dep of Addictions and Dependency, Sahlgrenska University Hostpital
Phone: +46313424724
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place