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Imaging the Neurobiology of a Behavioral Treatment for Cocaine Dependence (PET-CRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00376558
Recruitment Status : Completed
First Posted : September 15, 2006
Results First Posted : July 1, 2016
Last Update Posted : July 1, 2016
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cocaine Dependence
Intervention Behavioral: Community Reinforcement Approach
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cocaine Users Control Subjects
Hide Arm/Group Description Cocaine users receiving CRA Healthy controls who undergo scans
Period Title: Overall Study
Started 25 25
Completed 25 25
Not Completed 0 0
Arm/Group Title Cocaine Users Control Subjects Total
Hide Arm/Group Description Cocaine users receiving CRA Healthy controls who undergo scans Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
 100.0%
25
 100.0%
50
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
37  (7) 38  (6) 37  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
3
  12.0%
3
  12.0%
6
  12.0%
Male
22
  88.0%
22
  88.0%
44
  88.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 50 participants
25 25 50
1.Primary Outcome
Title Change From Baseline in the Binding Potential of [11C]Raclopride
Hide Description The relationship between Methylphenidate-induced Dopamine Release in the Striatum (Measured by Displacement of [11C]-Raclopride by Oral Methylphenidate) and Treatment Response (Measured Using Community Reinforcement Approach and Contingency Management) was studied. Dopamine Function was assessed by evaluation of endogenous Dopamine release over the course of treatment (i.e., at 3 months as compared to baseline). Endogenous Dopamine release is inversely related to the change in binding potential (delta BPND) of [11C]raclopride, in that a negative delta BPND, or increased displacement of [11C]raclopride, reflects an increase in the release of endogenous dopamine over the course of treatment.
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis for change in binding potential (binding potential difference; at baseline versus stimulant induced binding potential) was done with 24 cocaine users since one of the subjects only underwent baseline scanning. However, treatment data for all 25 cocaine users was used.
Arm/Group Title Cocaine Users Control Subjects
Hide Arm/Group Description:
Cocaine users receiving CRA
Healthy controls who undergo scans
Overall Number of Participants Analyzed 24 25
Mean (Standard Deviation)
Unit of Measure: ratio
-13.7  (8.7) -5.8  (8.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cocaine Users, Control Subjects
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Cocaine Craving, Withdrawal Symptoms, Pattern of Cocaine Use
Hide Description measurement of abstinence, measured as vouchers earned and clinical appointments attended using CRA
Time Frame 2x/week for 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of subjects was determined from previous studies using CM/CRA
Arm/Group Title Cocaine Abuser Undergoing CM With CRA Treatment
Hide Arm/Group Description:
Participants receive voucher points for each urine sample that tested negative for benzoylecgonine. Failure to submit a scheduled sample was treated as cocaine +. Voucher points have a monetary value that can be redeemed for goods/services that are approved by the therapist. Points ($0.25) were acquired on an escalating schedule that started at 10 points for the 1st cocaine-free sample, and each subsequent cocaine-free sample increased the value by 5 points. A bonus of 40 points ($10.00) for every 3 consecutive negative sample. Abstinence was confirmed by onsite urine test (Abuscreen On-Trak system, Roche Diagnostics). Missed clinic visits and urine samples that are considered + reset the points to the initial $2.50 value and the escalation schedule resume. Submission of 5 consecutive - samples after a + urine returns the voucher points to the value prior to reset. Points earned are never lost. A maximum of $997.50 is earned for submitting negative samples at all treatment visits.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: dollars
650  (0.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cocaine Abuser Undergoing CM With CRA Treatment
Comments The limbic striatum was our primary region of interest using an unpaired t test to compare BPND and deltaBPND between the treatment responders and non-responders.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter delta bpnd
Estimated Value -12
Parameter Dispersion
Type: Standard Deviation
Value: 7
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cocaine Users Control Subjects
Hide Arm/Group Description Cocaine users receiving CRA Healthy controls who undergo scans
All-Cause Mortality
Cocaine Users Control Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Cocaine Users Control Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/25 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cocaine Users Control Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/25 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Diana Martinez
Organization: nyspi
Phone: 212-543-6628
EMail: dm437@columbia.edu
Layout table for additonal information
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00376558    
Other Study ID Numbers: #5158
R01DA020855-02 ( U.S. NIH Grant/Contract )
First Submitted: September 14, 2006
First Posted: September 15, 2006
Results First Submitted: December 12, 2012
Results First Posted: July 1, 2016
Last Update Posted: July 1, 2016