Imaging the Neurobiology of a Behavioral Treatment for Cocaine Dependence

NCT00376558 | Completed Results DMC

• 2 other identifiers: #5158R01DA020855-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cocaine Dependence

Keywords

cocaine dependence

Outcome Measures

Primary Outcomes (1)

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

  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.

  baseline and 3 months

Secondary Outcomes (1)

• Cocaine Craving, Withdrawal Symptoms, Pattern of Cocaine Use

  2x/week for 24 weeks

Study Arms (2)

Contingency Management w/ CRA

ACTIVE COMPARATOR

Cocaine users: Contingency management w/ Community Reinforcement Approach

Behavioral: Community Reinforcement Approach

Healthy Control

NO INTERVENTION

A group of healthy matched comparison subjects with no DSM-IV axis I Disorder was included; they were matched for cigarette smoking, gender, and ethnicity.

Interventions

Community Reinforcement Approach BEHAVIORAL

Community Reinforcement Approach (CRA): The community reinforcement treatment program will be carried out in accordance with NIDA's therapy manual (13).During weeks 13 through 24, patients will meet once per week with their therapists. Sessions will focus on promoting continued change in the life areas addressed in the first 12 weeks of treatment or new components are added as needed.

Contingency Management w/ CRA

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 21406463 RESULT

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Cocaine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Diana Martinez
• Organization: nyspi

dm437@columbia.edu

212-543-6628

Study Officials

• Diana Martinez, MD

  Research Foundation for Mental Hygiene, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2006
• First Posted: September 15, 2006
• Study Start: July 1, 2006
• Primary Completion: July 1, 2010
• Study Completion: January 1, 2011
• Last Updated: July 1, 2016
• Results First Posted: July 1, 2016

Record last verified: 2016-05

Locations

US (1)