Trial Outcomes & Findings for Alcohol Self Administration Laboratory (NCT NCT00398918)

Results Overview

Grams Ethanol Consumed During Second Hour of the Alcohol Self-Administration Sessions for Zonisamide and Placebo Conditions

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

1 day

Results posted on

2017-07-14

Participant Flow

Participant milestones

Participant milestones
Measure	Zonisamide-Placebo Sessions In this within subjects study, subjects received zonisamide in one session and placebo in a second
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alcohol Self Administration Laboratory

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zonisamide-Placebo Sessions n=10 Participants In this within subjects study, subjects received zonisamide in one session and placebo in a second
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Population: This was a laboratory based study. An ITT analysis was used.

Grams Ethanol Consumed During Second Hour of the Alcohol Self-Administration Sessions for Zonisamide and Placebo Conditions

Outcome measures

Outcome measures
Measure	Zonisamide-Placebo Sessions n=10 Participants In this within subjects study, subjects received zonisamide in one session and placebo in a second
Grams Ethanol Consumed During Second Hour of the Alcohol Self-Administration Sessions Zonisamide	9.0 Grams Standard Error 3.7
Grams Ethanol Consumed During Second Hour of the Alcohol Self-Administration Sessions Placebo	18.2 Grams Standard Error 3.1

SECONDARY outcome

Timeframe: 40 minutes post alcohol ingestion

Population: ITT

Difference score between zonisamide and placebo treatment conditions for the Digit Symbol Modalities Test scores obtained 40 minutes after ingestion of a priming dose of ethanol.This test involves transcribing from a key in which numbers appear below a series of symbols to boxes below symbols matched to those in the key. This task must be completed in 90 nseconds. This test measures visuomotor speed and aspects of attention. Scoring is the total number of correctly transcribed numbers. The maximum score on this test 110 points.

Outcome measures

Outcome measures
Measure	Zonisamide-Placebo Sessions n=10 Participants In this within subjects study, subjects received zonisamide in one session and placebo in a second
Score Digit Symbol Modalities Test	2.2 Numeric Score Standard Error 5.7

Adverse Events

Zonisamide-Placebo Sessions

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ofra Sarid-Segal, MD

Boston University

Phone: 617-414-1990

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place