N/A
N=50
Imaging the Neurobiology of a Behavioral Treatment for Cocaine Dependence
Cocaine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00376558 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Change From Baseline in the Binding Potential of [11C]Raclopride — -13.7; -5.8 ratio — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Community Reinforcement Approach (Behavioral)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-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 |
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.
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
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.