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Phase 2 Completed N=131 Randomized Double-blind Treatment

Striatal Effective Connectivity to Predict Treatment Response in Cocaine Misuse

Cocaine Dependence
Source: ClinicalTrials.gov NCT02080819 ↗
Enrolled (actual)
131
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcomePrimary: Cocaine Treatment Outcome — 0; 14; 13 positive drug screens

Summary

This project proposes to investigate the role of brain connectivity in the mechanism of treatment response to dopaminergic medications in cocaine dependence.

Outcome Measures

OutcomeResultp-value
PRIMARY
Cocaine Treatment Outcome
0; 14; 13

Eligibility Criteria

Inclusion Criteria

  • Male and female subjects
  • Age 18 to 50
  • 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 levodopa/carbidopa or pharmacotherapy (e.g., evidence of any movement disorder, clinically significant pulmonary disease, cardiovascular disease, liver or kidney disease, seizure disorder)
  • Taking CNS active concomitant medications
  • Taking medications known to have significant drug interactions with the study medication (e.g., CYP P-450-2D6 inhibitors, such as tamoxifen, iron salts, pyridoxine, monoamine oxidase inhibitors, phenothiazines, selegiline, anesthetics)
  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02080819). 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. Informational only — not medical advice.

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