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

• 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: New York State Psychiatric Institute
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Cocaine Users	Control Subjects
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

Baseline Characteristics

Arm/Group Title		Cocaine Users	Control Subjects	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in the Binding Potential of [11C]Raclopride
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

Outcome Measure Data

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
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)

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
Description	measurement of abstinence, measured as vouchers earned and clinical appointments attended using CRA
Time Frame	2x/week for 24 weeks

Outcome Measure Data

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
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)

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]

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Cocaine Users	Control Subjects
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	--/--	--/--
Serious Adverse Events
	Cocaine Users	Control Subjects
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/24 (0.00%)	0/25 (0.00%)
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%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Diana Martinez
• Organization: nyspi
• Phone: 212-543-6628
• EMail: dm437@columbia.edu

Publications of Results:

Martinez D, Carpenter KM, Liu F, Slifstein M, Broft A, Friedman AC, Kumar D, Van Heertum R, Kleber HD, Nunes E. Imaging dopamine transmission in cocaine dependence: link between neurochemistry and response to treatment. Am J Psychiatry. 2011 Jun;168(6):634-41. doi: 10.1176/appi.ajp.2010.10050748. Epub 2011 Mar 15. Erratum in: Am J Psychiatry. 2011 May;168(5):553.

• 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