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N/A Completed N=50 Treatment

Imaging the Neurobiology of a Behavioral Treatment for Cocaine Dependence

Cocaine Dependence
Source: ClinicalTrials.gov NCT00376558 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcomePrimary: Change From Baseline in the Binding Potential of [11C]Raclopride — -13.7; -5.8 ratio — p=0.003

Summary

The purpose of this study is to determine whether patients with the greatest loss of dopamine transmission due to cocaine dependence at pre-treatment PET and MRI scans will be those who fail to respond to substance abuse treatment. This study will also determine whether patients who do respond to treatment will experience a recovery of dopamine function. This study includes free brain imaging and behavioral intervention. Compensation provided for the brain scans.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in the Binding Potential of [11C]Raclopride
-13.7; -5.8 0.003 sig
SECONDARY
Cocaine Craving, Withdrawal Symptoms, Pattern of Cocaine Use
650 0.001 sig

Eligibility Criteria

Inclusion Criteria

  • Males or females between 21 and 45 years old
  • Fulfill DSMIV criteria for cocaine abuse or dependence
  • Able to give informed consent and comply with study procedures
  • Medically Healthy

Exclusion Criteria

  • Major DSM-IV Axis I disorder other than cocaine abuse or dependence. Subjects with a history of other psychostimulant abuse/dependence or compulsive gambling will be excluded.
  • Current use of opiates, sedative-hypnotic, and/or cannabis more than twice a week (use less than twice a week is acceptable).
  • Current use of psychotropic medication such as antipsychotics or antidepressants.
  • Presence or positive history of severe medical or neurological illness (including epilepsy), or any cardiovascular disease, low hemoglobin (Hb 2-3 times normal. Chronic active hepatitis B or C will also be an exclusion criteria.
  • Resting SBP >150, DBP > 90
  • Pregnancy or lactation, lack of effective birth control during 15 days before the scans*
  • Evidence /report of any heart abnormality during intake medical history, EKG or physical exam.
  • Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan, as determined in consultation with a neuroradiologist and according to the guidelines set forth in the following reference book commonly used by neuroradiologists: "Guide to MR procedures and metallic objects" Shellock, PhD, Lippincott Williams and Wilkins, NY 2001.
  • Lifetime exposure to radiation in the workplace, or history of participation in nuclear medicine procedures, including research protocols **
  • Positive Allen Test indicating lack of collateral blood flow to hand
  • History of sensitivity to methylphenidate
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00376558). 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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