Phase 3
N=23
Clinical Neurobiology of Serotonin and Addiction
Cocaine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00732901 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Immediate Memory Task
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Escitalopram (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immediate Memory Task |
— | — |
| SECONDARY Attentional Bias as Measured by the Cocaine Stroop Task. |
90.2; 45.9; -8.6; 37.4; 56.4; 35.4 | — |
| SECONDARY Cocaine Positive Urines |
9; 8 | — |
Summary
The purpose of this study is to examine the relationship between 5-HT2R function, impulsivity and cue reactivity in cocaine dependent subjects and healthy controls and examine specific effects of escitalopram and mirtazapine on impulsivity and cue reactivity in human cocaine users.
Eligibility Criteria
Inclusion Criteria
- Non-Drug Abusing Control Subjects: Male and female subjects age 18 to 55 who do not meet current or past DSM-IV criteria for any Axis I disorder including substance abuse or dependence.
- Cocaine Dependent Subjects: Male and female subjects age 18 to 55 who meet current DSM-IV criteria for cocaine dependence.
- Female subjects: a negative pregnancy test.
Exclusion Criteria
- Non-Drug Abusing Control Subjects:
- Current or past DSM-IV Axis I disorder
- Any serious non-psychiatric medical illness requiring ongoing medical treatment or which could affect the central nervous system.
- Positive HIV test.
- For female subjects: a positive pregnancy test or breast feeding.
- Concomitant use of prescription medications that could affect the central nervous system.
- Active suicidal ideation.
- Hamilton Depression or Anxiety Scale score greater than 15
- Cocaine Dependent Subjects:
- Current DSM-IV Axis I disorder other than substance abuse/dependence
- Current diagnosis of other substance dependence besides cocaine.
- Any serious non-psychiatric medical illness requiring ongoing medical treatment or which could affect the central nervous system.
- Positive HIV test.
- For female subjects: a positive pregnancy test or breast feeding.
- Concomitant use of prescription medications that could affect the central nervous system.
- Active suicidal ideation.
- Subjects within 14 days of discontinuing a monoamine oxidase inhibitor.
- Subjects with cardiac arrythmias.
- Subjects with known hypersensitivity to escitalopram or citalopram, or mirtazapine
- Hamilton Depression or Anxiety Scale score greater than 15.
- Current alcohol abuse or dependence.
Data sourced from ClinicalTrials.gov (NCT00732901). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.