Phase 2
N=54
Brain Function and Structure in Cocaine Dependence
Cocaine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT02080832 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Cocaine Use/Treatment Effectiveness Score (TES) — 6.6; 8.3; 29 percentage of negative urines
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Citalopram (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cocaine Use/Treatment Effectiveness Score (TES) |
6.6; 8.3; 29 | — |
Summary
The purpose of this study is to examine the role of brain MRI findings in predicting treatment outcomes among individuals with cocaine dependence.
Eligibility Criteria
Inclusion Criteria
- Male and female subjects age 18 to 50 who meet current DSM-IV criteria for cocaine dependence who are seeking treatment.
Exclusion Criteria
- Current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine, marijuana, nicotine, or alcohol
- Have a DSM-IV axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
- Significant current suicidal or homicidal ideation
- Medical conditions contraindicating citalopram pharmacotherapy (liver disease, seizure disorder, bleeding disorder, or prolonged QT interval on EKG)
- Taking CNS active concomitant medications
- Taking medications known to have significant drug interactions with the study medication
- Having conditions of probation or parole requiring reports of drug use to officers of the court
- Impending incarceration
- Pregnant or breast feeding for female patients
- Inability to read, write, or speak English
- Having plans to leave the immediate geographical area within 3 months
- Unwillingness or not competent to sign a written informed consent form
- Individuals who have pacemakers, metal or electromechanical implants or metallic foreign bodies
- Patients who are known to be HIV positive will not be included due to possible CNS effects of HIV.
- Alcohol withdrawal symptoms or history of significant previous alcohol withdrawal symptoms.
Data sourced from ClinicalTrials.gov (NCT02080832). 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.