Trial Outcomes & Findings for Duloxetine Versus Pregabalin for Alcohol Dependence (NCT NCT00929344)

Last Updated: 2017-05-04

Results Overview

Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

150 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2017-05-04

Participant Flow

Participant milestones

Participant milestones
Measure	Duloxetine Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration.	Pregabalin Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration.	Placebo Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration.
Overall Study STARTED	50	50	50
Overall Study COMPLETED	28	37	29
Overall Study NOT COMPLETED	22	13	21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Duloxetine Versus Pregabalin for Alcohol Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Duloxetine n=50 Participants Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration.	Pregabalin n=50 Participants Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration.	Placebo n=50 Participants Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration.	Total n=150 Participants Total of all reporting groups
Age, Continuous	44.86 years STANDARD_DEVIATION 10.53 • n=5 Participants	44.56 years STANDARD_DEVIATION 11.55 • n=7 Participants	43.54 years STANDARD_DEVIATION 10.52 • n=5 Participants	44.32 years STANDARD_DEVIATION 10.82 • n=4 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants	55 Participants n=4 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	37 Participants n=7 Participants	27 Participants n=5 Participants	95 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Outcome measures

Outcome measures
Measure	Duloxetine n=28 Participants Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration.	Pregabalin n=37 Participants Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration.	Placebo n=29 Participants Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration.
Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12 Drinks/week Baseline	42.07 drinks/week Standard Deviation 17.94	56.67 drinks/week Standard Deviation 50.93	41.20 drinks/week Standard Deviation 27.39
Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12 Drinks/week Week 12	9.16 drinks/week Standard Deviation 11.90	7.59 drinks/week Standard Deviation 15.73	8.06 drinks/week Standard Deviation 11.22
Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Week at Week 12 Drinks/week Change	-32.91 drinks/week Standard Deviation 20.38	-49.08 drinks/week Standard Deviation 44.91	-33.15 drinks/week Standard Deviation 23.32

PRIMARY outcome

Timeframe: Baseline and Week 12

Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol.

Outcome measures

Outcome measures
Measure	Duloxetine n=28 Participants Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration.	Pregabalin n=37 Participants Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration.	Placebo n=29 Participants Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration.
Change From Baseline in Drinking Quantity and Frequency Using Drinking Days Per Week at Week 12 Drinking Days/Week Baseline	5.11 drinking days/week Standard Deviation 1.29	4.54 drinking days/week Standard Deviation 1.64	4.87 drinking days/week Standard Deviation 1.60
Change From Baseline in Drinking Quantity and Frequency Using Drinking Days Per Week at Week 12 Drinking Days/Week Week 12	2.17 drinking days/week Standard Deviation 2.59	1.14 drinking days/week Standard Deviation 1.90	1.85 drinking days/week Standard Deviation 2.20
Change From Baseline in Drinking Quantity and Frequency Using Drinking Days Per Week at Week 12 Drinking Days/Week Change	-2.94 drinking days/week Standard Deviation 2.68	-3.40 drinking days/week Standard Deviation 2.03	-3.01 drinking days/week Standard Deviation 2.20

PRIMARY outcome

Timeframe: Baseline and Week 12

Outcome measures

Outcome measures
Measure	Duloxetine n=28 Participants Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration.	Pregabalin n=37 Participants Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration.	Placebo n=29 Participants Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration.
Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Drinking Day at Week 12 Drinks/Drinking Day Baseline	8.16 drinks/drinking day Standard Deviation 2.69	12.98 drinks/drinking day Standard Deviation 11.14	8.91 drinks/drinking day Standard Deviation 5.41
Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Drinking Day at Week 12 Drinks/Drinking Day Week 12	2.21 drinks/drinking day Standard Deviation 2.65	2.31 drinks/drinking day Standard Deviation 3.81	2.90 drinks/drinking day Standard Deviation 3.62
Change From Baseline in Drinking Quantity and Frequency Using Drinks Per Drinking Day at Week 12 Drinks/Drinking Day Change	-5.94 drinks/drinking day Standard Deviation 3.54	-10.67 drinks/drinking day Standard Deviation 11.34	-6.01 drinks/drinking day Standard Deviation 4.84

Adverse Events

Duloxetine

Serious events: 2 serious events

Other events: 43 other events

Deaths: 0 deaths

Pregabalin

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Duloxetine n=50 participants at risk Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration.	Pregabalin n=50 participants at risk Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration.	Placebo n=50 participants at risk Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration. Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration.
Cardiac disorders Cardiac failure congestive	0.00% 0/50 • Adverse event data was collected weekly at all 14 study visits during the double blind portion of the study, an average duration of 12 weeks. Adverse event data was also collected during two additional follow up visits, at Weeks 13 and 24. Adverse events, both serious and other, were documented at all 16 study visits by the Medical Assistant on the adverse event case report form.	0.00% 0/50 • Adverse event data was collected weekly at all 14 study visits during the double blind portion of the study, an average duration of 12 weeks. Adverse event data was also collected during two additional follow up visits, at Weeks 13 and 24. Adverse events, both serious and other, were documented at all 16 study visits by the Medical Assistant on the adverse event case report form.	2.0% 1/50 • Adverse event data was collected weekly at all 14 study visits during the double blind portion of the study, an average duration of 12 weeks. Adverse event data was also collected during two additional follow up visits, at Weeks 13 and 24. Adverse events, both serious and other, were documented at all 16 study visits by the Medical Assistant on the adverse event case report form.
General disorders Chest pain	0.00% 0/50 • Adverse event data was collected weekly at all 14 study visits during the double blind portion of the study, an average duration of 12 weeks. Adverse event data was also collected during two additional follow up visits, at Weeks 13 and 24. Adverse events, both serious and other, were documented at all 16 study visits by the Medical Assistant on the adverse event case report form.	0.00% 0/50 • Adverse event data was collected weekly at all 14 study visits during the double blind portion of the study, an average duration of 12 weeks. Adverse event data was also collected during two additional follow up visits, at Weeks 13 and 24. Adverse events, both serious and other, were documented at all 16 study visits by the Medical Assistant on the adverse event case report form.	2.0% 1/50 • Adverse event data was collected weekly at all 14 study visits during the double blind portion of the study, an average duration of 12 weeks. Adverse event data was also collected during two additional follow up visits, at Weeks 13 and 24. Adverse events, both serious and other, were documented at all 16 study visits by the Medical Assistant on the adverse event case report form.
Infections and infestations Gastrointestinal protozoal infection	0.00% 0/50 • Adverse event data was collected weekly at all 14 study visits during the double blind portion of the study, an average duration of 12 weeks. Adverse event data was also collected during two additional follow up visits, at Weeks 13 and 24. Adverse events, both serious and other, were documented at all 16 study visits by the Medical Assistant on the adverse event case report form.	0.00% 0/50 • Adverse event data was collected weekly at all 14 study visits during the double blind portion of the study, an average duration of 12 weeks. Adverse event data was also collected during two additional follow up visits, at Weeks 13 and 24. Adverse events, both serious and other, were documented at all 16 study visits by the Medical Assistant on the adverse event case report form.	2.0% 1/50 • Adverse event data was collected weekly at all 14 study visits during the double blind portion of the study, an average duration of 12 weeks. Adverse event data was also collected during two additional follow up visits, at Weeks 13 and 24. Adverse events, both serious and other, were documented at all 16 study visits by the Medical Assistant on the adverse event case report form.
Infections and infestations Influenza	0.00% 0/50 • Adverse event data was collected weekly at all 14 study visits during the double blind portion of the study, an average duration of 12 weeks. Adverse event data was also collected during two additional follow up visits, at Weeks 13 and 24. Adverse events, both serious and other, were documented at all 16 study visits by the Medical Assistant on the adverse event case report form.	0.00% 0/50 • Adverse event data was collected weekly at all 14 study visits during the double blind portion of the study, an average duration of 12 weeks. Adverse event data was also collected during two additional follow up visits, at Weeks 13 and 24. Adverse events, both serious and other, were documented at all 16 study visits by the Medical Assistant on the adverse event case report form.	2.0% 1/50 • Adverse event data was collected weekly at all 14 study visits during the double blind portion of the study, an average duration of 12 weeks. Adverse event data was also collected during two additional follow up visits, at Weeks 13 and 24. Adverse events, both serious and other, were documented at all 16 study visits by the Medical Assistant on the adverse event case report form.
Injury, poisoning and procedural complications Spinal fracture	2.0% 1/50 • Adverse event data was collected weekly at all 14 study visits during the double blind portion of the study, an average duration of 12 weeks. Adverse event data was also collected during two additional follow up visits, at Weeks 13 and 24. Adverse events, both serious and other, were documented at all 16 study visits by the Medical Assistant on the adverse event case report form.	0.00% 0/50 • Adverse event data was collected weekly at all 14 study visits during the double blind portion of the study, an average duration of 12 weeks. Adverse event data was also collected during two additional follow up visits, at Weeks 13 and 24. Adverse events, both serious and other, were documented at all 16 study visits by the Medical Assistant on the adverse event case report form.	0.00% 0/50 • Adverse event data was collected weekly at all 14 study visits during the double blind portion of the study, an average duration of 12 weeks. Adverse event data was also collected during two additional follow up visits, at Weeks 13 and 24. Adverse events, both serious and other, were documented at all 16 study visits by the Medical Assistant on the adverse event case report form.
Psychiatric disorders Suicidal ideation	0.00% 0/50 • Adverse event data was collected weekly at all 14 study visits during the double blind portion of the study, an average duration of 12 weeks. Adverse event data was also collected during two additional follow up visits, at Weeks 13 and 24. Adverse events, both serious and other, were documented at all 16 study visits by the Medical Assistant on the adverse event case report form.	0.00% 0/50 • Adverse event data was collected weekly at all 14 study visits during the double blind portion of the study, an average duration of 12 weeks. Adverse event data was also collected during two additional follow up visits, at Weeks 13 and 24. Adverse events, both serious and other, were documented at all 16 study visits by the Medical Assistant on the adverse event case report form.	2.0% 1/50 • Adverse event data was collected weekly at all 14 study visits during the double blind portion of the study, an average duration of 12 weeks. Adverse event data was also collected during two additional follow up visits, at Weeks 13 and 24. Adverse events, both serious and other, were documented at all 16 study visits by the Medical Assistant on the adverse event case report form.
Respiratory, thoracic and mediastinal disorders Asthma	2.0% 1/50 • Adverse event data was collected weekly at all 14 study visits during the double blind portion of the study, an average duration of 12 weeks. Adverse event data was also collected during two additional follow up visits, at Weeks 13 and 24. Adverse events, both serious and other, were documented at all 16 study visits by the Medical Assistant on the adverse event case report form.	0.00% 0/50 • Adverse event data was collected weekly at all 14 study visits during the double blind portion of the study, an average duration of 12 weeks. Adverse event data was also collected during two additional follow up visits, at Weeks 13 and 24. Adverse events, both serious and other, were documented at all 16 study visits by the Medical Assistant on the adverse event case report form.	0.00% 0/50 • Adverse event data was collected weekly at all 14 study visits during the double blind portion of the study, an average duration of 12 weeks. Adverse event data was also collected during two additional follow up visits, at Weeks 13 and 24. Adverse events, both serious and other, were documented at all 16 study visits by the Medical Assistant on the adverse event case report form.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/50 • Adverse event data was collected weekly at all 14 study visits during the double blind portion of the study, an average duration of 12 weeks. Adverse event data was also collected during two additional follow up visits, at Weeks 13 and 24. Adverse events, both serious and other, were documented at all 16 study visits by the Medical Assistant on the adverse event case report form.	0.00% 0/50 • Adverse event data was collected weekly at all 14 study visits during the double blind portion of the study, an average duration of 12 weeks. Adverse event data was also collected during two additional follow up visits, at Weeks 13 and 24. Adverse events, both serious and other, were documented at all 16 study visits by the Medical Assistant on the adverse event case report form.	4.0% 2/50 • Adverse event data was collected weekly at all 14 study visits during the double blind portion of the study, an average duration of 12 weeks. Adverse event data was also collected during two additional follow up visits, at Weeks 13 and 24. Adverse events, both serious and other, were documented at all 16 study visits by the Medical Assistant on the adverse event case report form.

Other adverse events

Additional Information

Barbara J. Mason, Ph.D.

The Scripps Research Institute

Phone: 858-784-7328

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place