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Clinical Neurobiology of Serotonin and Addiction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00732901
Recruitment Status : Completed
First Posted : August 12, 2008
Results First Posted : March 30, 2017
Last Update Posted : March 8, 2019
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Cocaine Dependence
Interventions Drug: Escitalopram
Drug: Placebo
Enrollment 160
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title A (Escitalopram) B (Placebo)
Hide Arm/Group Description

Escitalopram

Escitalopram: once daily 10 mg on days 1-3, 20 mg on days 4-24 and 10 mg on days 25-28

Placebo

Placebo: once daily for days 1-28

Period Title: Overall Study
Started 11 12
Completed 11 12
Not Completed 0 0
Arm/Group Title A (Escitalopram) B (Placebo) Total
Hide Arm/Group Description Escitalopram: once daily 10 mg on days 1-3, 20 mg on days 4-24 and 10 mg on days 25-28 Placebo once daily for days 1-28 Total of all reporting groups
Overall Number of Baseline Participants 11 12 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 23 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
 100.0%
12
 100.0%
23
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 12 participants 23 participants
38.4  (7.88) 41.75  (6.65) 40.01  (7.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 23 participants
Female
1
   9.1%
1
   8.3%
2
   8.7%
Male
10
  90.9%
11
  91.7%
21
  91.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 12 participants 23 participants
11 12 23
1.Primary Outcome
Title Immediate Memory Task
Hide Description 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.
Time Frame after acute dose and after chronic administration
Hide Outcome Measure Data
Hide Analysis Population Description
Numerical data values are not accessible because PI transferred institutions. See references.
Arm/Group Title A (Escitalopram) B (Placebo)
Hide Arm/Group Description:

Escitalopram

Escitalopram: 10 mg daily for days 1-3, 20mg daily for days 4-24, and 10mg daily for days 25-28

Placebo

Placebo: daily for days 1-28

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Attentional Bias as Measured by the Cocaine Stroop Task.
Hide Description Attentional bias is the difference in reaction time to cocaine related words and neutral words. A slower reaction time indicates greater attentional bias.
Time Frame 5 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A (Escitalopram) B (Placebo)
Hide Arm/Group Description:

Escitalopram

Escitalopram: 10 mg daily for days 1-3, 20mg daily for days 4-24, and 10mg daily for days 25-28

Placebo

Placebo: daily for days 1-28

Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: milliseconds
Baseline 90.2  (107.8) 45.9  (109.2)
Acute -8.6  (21.6) 37.4  (93.8)
Chronic Day 1 56.4  (58.7) 35.4  (77.9)
Chronic Day 2 45.0  (68.6) 15.4  (64.5)
Chronic Day 3 23.4  (33.0) -11.3  (68.0)
Chronic Day 4 63.6  (82.5) 4.4  (76.2)
3.Secondary Outcome
Title Cocaine Positive Urines
Hide Description Number of urine drug screens positive for cocaine metabolite benzoylecgonine.
Time Frame 5 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A (Escitalopram) B (Placebo)
Hide Arm/Group Description:

Escitalopram

Escitalopram: 10 mg daily for days 1-3, 20mg daily for days 4-24, and 10mg daily for days 25-28

Placebo

Placebo: daily for days 1-28

Overall Number of Participants Analyzed 11 12
Measure Type: Number
Unit of Measure: Positive urine drug screens
9 8
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A (Escitalopram) B (Placebo)
Hide Arm/Group Description

Escitalopram

Escitalopram: once daily 10 mg on days 1-3, 20 mg on days 4-24 and 10 mg on days 25-28

Placebo

Placebo: once daily for days 1-28

All-Cause Mortality
A (Escitalopram) B (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
A (Escitalopram) B (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/12 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
A (Escitalopram) B (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/12 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: F. Gerard Moeller
Organization: Virginia Commonwealth University
Phone: 804-828-4134
EMail: fgmoeller@vcu.edu
Layout table for additonal information
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00732901    
Other Study ID Numbers: HM15289 - 2
P20DA024157 ( U.S. NIH Grant/Contract )
DA 024157 ( Other Identifier )
First Submitted: August 8, 2008
First Posted: August 12, 2008
Results First Submitted: July 20, 2016
Results First Posted: March 30, 2017
Last Update Posted: March 8, 2019