Trial Outcomes & Findings for Sertraline Pharmacotherapy for Alcoholism Subtypes (NCT NCT00368550)

Results Overview

Obtained using daily interactive voice response data augmented by Timeline Followback data. Missing days were treated as drinking days.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

134 participants

Primary outcome timeframe

12-week treatment period

Results posted on

2011-06-21

Participant Flow

Recruitment from Feb. 2004 to March 2009 through advertisements and referrals by area clinicians.

All patients underwent physical examination and routine laboratory testing during screening. 143 prospective patients were screened, of which 4 did not meet study criteria and 5 chose not to participate.

Participant milestones

Participant milestones
Measure	Sertraline Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients' ability to change their drinking behavior, was provided at each visit.	Placebo Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients' ability to change their drinking behavior, was provided at each visit.
Overall Study STARTED	63	71
Overall Study COMPLETED	35	48
Overall Study NOT COMPLETED	28	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Sertraline Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients' ability to change their drinking behavior, was provided at each visit.	Placebo Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients' ability to change their drinking behavior, was provided at each visit.
Overall Study Adverse Event	7	4
Overall Study Lack of Efficacy	4	9
Overall Study Withdrawal by Subject	17	10

Baseline Characteristics

Sertraline Pharmacotherapy for Alcoholism Subtypes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sertraline n=63 Participants Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients' ability to change their drinking behavior, was provided at each visit.	Placebo n=71 Participants Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients' ability to change their drinking behavior, was provided at each visit.	Total n=134 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	62 Participants n=99 Participants	71 Participants n=107 Participants	133 Participants n=206 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Age Continuous	47.7 years STANDARD_DEVIATION 10.1 • n=99 Participants	47.3 years STANDARD_DEVIATION 9.5 • n=107 Participants	47.5 years STANDARD_DEVIATION 9.8 • n=206 Participants
Sex: Female, Male Female	12 Participants n=99 Participants	14 Participants n=107 Participants	26 Participants n=206 Participants
Sex: Female, Male Male	51 Participants n=99 Participants	57 Participants n=107 Participants	108 Participants n=206 Participants
Region of Enrollment United States	63 participants n=99 Participants	71 participants n=107 Participants	134 participants n=206 Participants

PRIMARY outcome

Timeframe: 12-week treatment period

Population: All randomized subjects with missing days imputed as drinking days.

Obtained using daily interactive voice response data augmented by Timeline Followback data. Missing days were treated as drinking days.

Outcome measures

Outcome measures
Measure	Sertraline n=63 Participants Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients' ability to change their drinking behavior, was provided at each visit.	Placebo n=71 Participants Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients' ability to change their drinking behavior, was provided at each visit.
Number of Days on Which Subjects Drank	37.0 days Standard Deviation 30.6	33.8 days Standard Deviation 27.3

SECONDARY outcome

Timeframe: 12-week treatment period

Obtained using daily interactive voice response data augmented by Timeline Followback data. Missing days were treated as heavy drinking days.

Outcome measures

Outcome measures
Measure	Sertraline n=63 Participants Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients' ability to change their drinking behavior, was provided at each visit.	Placebo n=71 Participants Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients' ability to change their drinking behavior, was provided at each visit.
Number of Days of Heavy Drinking (Defined as Days on Which Women Drank >= 4 Drinks and Men Drank >= 5 Drinks)	31.9 days Standard Deviation 29.0	26.4 days Standard Deviation 26.4

SECONDARY outcome

Timeframe: 12-week treatment period compared with baseline value

Measured using the SIP (Short Inventory of Problems), which was administered at pretreatment and at the end of treatment. The range of scores on the SIP is 0 (no alcohol-related problems) to 45 (most severe alcohol-related problems) and the time frame for reporting is the preceding 3 months. The data presented here represent a difference score of treatment minus baseline.

Outcome measures

Outcome measures
Measure	Sertraline n=63 Participants Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients' ability to change their drinking behavior, was provided at each visit.	Placebo n=71 Participants Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients' ability to change their drinking behavior, was provided at each visit.
Change in the Level of Alcohol-related Problems	6.0 Units on a scale Standard Deviation 9.2	9.0 Units on a scale Standard Deviation 9.5

Adverse Events

Sertraline

Serious events: 3 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sertraline n=63 participants at risk Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients' ability to change their drinking behavior, was provided at each visit.	Placebo n=71 participants at risk Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients' ability to change their drinking behavior, was provided at each visit.
Cardiac disorders Hospitalization due to chest pain	1.6% 1/63 • Number of events 1 • 14 weeks Items used to monitor the occurrence of adverse events are those identified in previously completed efficacy studies of sertraline.	0.00% 0/71 • 14 weeks Items used to monitor the occurrence of adverse events are those identified in previously completed efficacy studies of sertraline.
Psychiatric disorders Hospitalization due to relapse to heavy drinking	3.2% 2/63 • Number of events 2 • 14 weeks Items used to monitor the occurrence of adverse events are those identified in previously completed efficacy studies of sertraline.	0.00% 0/71 • 14 weeks Items used to monitor the occurrence of adverse events are those identified in previously completed efficacy studies of sertraline.

Other adverse events

Other adverse events
Measure	Sertraline n=63 participants at risk Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients' ability to change their drinking behavior, was provided at each visit.	Placebo n=71 participants at risk Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients' ability to change their drinking behavior, was provided at each visit.
Psychiatric disorders agitation	3.2% 2/63 • Number of events 2 • 14 weeks Items used to monitor the occurrence of adverse events are those identified in previously completed efficacy studies of sertraline.	7.0% 5/71 • Number of events 5 • 14 weeks Items used to monitor the occurrence of adverse events are those identified in previously completed efficacy studies of sertraline.
Gastrointestinal disorders nausea	11.1% 7/63 • Number of events 7 • 14 weeks Items used to monitor the occurrence of adverse events are those identified in previously completed efficacy studies of sertraline.	9.9% 7/71 • Number of events 7 • 14 weeks Items used to monitor the occurrence of adverse events are those identified in previously completed efficacy studies of sertraline.
Psychiatric disorders insomnia	9.5% 6/63 • Number of events 6 • 14 weeks Items used to monitor the occurrence of adverse events are those identified in previously completed efficacy studies of sertraline.	9.9% 7/71 • Number of events 8 • 14 weeks Items used to monitor the occurrence of adverse events are those identified in previously completed efficacy studies of sertraline.
Gastrointestinal disorders diarrhea	25.4% 16/63 • Number of events 21 • 14 weeks Items used to monitor the occurrence of adverse events are those identified in previously completed efficacy studies of sertraline.	14.1% 10/71 • Number of events 13 • 14 weeks Items used to monitor the occurrence of adverse events are those identified in previously completed efficacy studies of sertraline.
Reproductive system and breast disorders sexual problems	23.8% 15/63 • Number of events 17 • 14 weeks Items used to monitor the occurrence of adverse events are those identified in previously completed efficacy studies of sertraline.	4.2% 3/71 • Number of events 4 • 14 weeks Items used to monitor the occurrence of adverse events are those identified in previously completed efficacy studies of sertraline.
Nervous system disorders tired/sleepy	20.6% 13/63 • Number of events 15 • 14 weeks Items used to monitor the occurrence of adverse events are those identified in previously completed efficacy studies of sertraline.	5.6% 4/71 • Number of events 4 • 14 weeks Items used to monitor the occurrence of adverse events are those identified in previously completed efficacy studies of sertraline.
Nervous system disorders decreased appetite	6.3% 4/63 • Number of events 4 • 14 weeks Items used to monitor the occurrence of adverse events are those identified in previously completed efficacy studies of sertraline.	0.00% 0/71 • 14 weeks Items used to monitor the occurrence of adverse events are those identified in previously completed efficacy studies of sertraline.

Additional Information

Henry R. Kranzler, M.D.

University of Pennsylvania

Phone: 215-222-3200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place