Trial Outcomes & Findings for Clinical Neurobiology of Serotonin and Addiction (NCT NCT00732901)

Results Overview

The IMT was used to measure impulsivity. The IMT is a continuous performance test. Subjects were instructed to respond on the computer's left mouse button when a five-digit number the target stimulus appeared that was exactly like the preceding stimulus. A catch stimulus was a number that differed only slightly from the preceding number. Only one of the five digits was changed its position and value was determined randomly. Responses errors made to catch stimuli were considered commission errors or 'false alarms'. Immediate Memory Task Commission Errors to catch stimuli were the primary measure of impulsivity in this study. Scale is percentage of overall responses to a catch stimulus that were commission errors, ranging from 0 to 100. Zero would equate to no impulsivity and 100 would equate to 100% impulsive responses.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

160 participants

Primary outcome timeframe

after acute dose and after chronic administration

Results posted on

2019-03-08

Participant Flow

The enrollment number was the number of participants who signed the informed consent. The Participants who Started in the Participant flow module were number of participants who completed the screening and met inclusion criteria to start medication.

Participant milestones

Participant milestones
Measure	A (Escitalopram) Escitalopram Escitalopram: once daily 10 mg on days 1-3, 20 mg on days 4-24 and 10 mg on days 25-28	B (Placebo) Placebo Placebo: once daily for days 1-28
Overall Study STARTED	11	12
Overall Study COMPLETED	11	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Neurobiology of Serotonin and Addiction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A (Escitalopram) n=11 Participants Escitalopram: once daily 10 mg on days 1-3, 20 mg on days 4-24 and 10 mg on days 25-28	B (Placebo) n=12 Participants Placebo once daily for days 1-28	Total n=23 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	38.4 years STANDARD_DEVIATION 7.88 • n=5 Participants	41.75 years STANDARD_DEVIATION 6.65 • n=7 Participants	40.01 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	12 participants n=7 Participants	23 participants n=5 Participants

PRIMARY outcome

Timeframe: after acute dose and after chronic administration

Population: Numerical data values are not accessible because PI transferred institutions. See references.

The IMT was used to measure impulsivity. The IMT is a continuous performance test. Subjects were instructed to respond on the computer's left mouse button when a five-digit number the target stimulus appeared that was exactly like the preceding stimulus. A catch stimulus was a number that differed only slightly from the preceding number. Only one of the five digits was changed its position and value was determined randomly. Responses errors made to catch stimuli were considered commission errors or 'false alarms'. Immediate Memory Task Commission Errors to catch stimuli were the primary measure of impulsivity in this study. Scale is percentage of overall responses to a catch stimulus that were commission errors, ranging from 0 to 100. Zero would equate to no impulsivity and 100 would equate to 100% impulsive responses.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 weeks of treatment

Attentional bias is the difference in reaction time to cocaine related words and neutral words. A slower reaction time indicates greater attentional bias.

Outcome measures

Outcome measures
Measure	A (Escitalopram) n=11 Participants Escitalopram Escitalopram: 10 mg daily for days 1-3, 20mg daily for days 4-24, and 10mg daily for days 25-28	B (Placebo) n=12 Participants Placebo Placebo: daily for days 1-28
Attentional Bias as Measured by the Cocaine Stroop Task. Baseline	90.2 milliseconds Standard Deviation 107.8	45.9 milliseconds Standard Deviation 109.2
Attentional Bias as Measured by the Cocaine Stroop Task. Acute	-8.6 milliseconds Standard Deviation 21.6	37.4 milliseconds Standard Deviation 93.8
Attentional Bias as Measured by the Cocaine Stroop Task. Chronic Day 1	56.4 milliseconds Standard Deviation 58.7	35.4 milliseconds Standard Deviation 77.9
Attentional Bias as Measured by the Cocaine Stroop Task. Chronic Day 2	45.0 milliseconds Standard Deviation 68.6	15.4 milliseconds Standard Deviation 64.5
Attentional Bias as Measured by the Cocaine Stroop Task. Chronic Day 3	23.4 milliseconds Standard Deviation 33.0	-11.3 milliseconds Standard Deviation 68.0
Attentional Bias as Measured by the Cocaine Stroop Task. Chronic Day 4	63.6 milliseconds Standard Deviation 82.5	4.4 milliseconds Standard Deviation 76.2

SECONDARY outcome

Timeframe: 5 weeks of treatment

Number of urine drug screens positive for cocaine metabolite benzoylecgonine.

Outcome measures

Outcome measures
Measure	A (Escitalopram) n=11 Participants Escitalopram Escitalopram: 10 mg daily for days 1-3, 20mg daily for days 4-24, and 10mg daily for days 25-28	B (Placebo) n=12 Participants Placebo Placebo: daily for days 1-28
Cocaine Positive Urines	9 Positive urine drug screens	8 Positive urine drug screens

Adverse Events

A (Escitalopram)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

B (Placebo)

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

F. Gerard Moeller

Virginia Commonwealth University

Phone: 804-828-4134

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place