Imaging the Neurobiology of Behavioral and Medication Treatment for Cocaine Dependence

NCT01468012 | Completed Phase 2 Results DMC

• 2 other identifiers: #60226022
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study will look at cocaine dependent individuals and will consist of three consecutive phases: 1) the 2-week outpatient lead-in phase during which behavioral therapy will be administered; 2) the 15-21 day inpatient phase (during which participants will start study medication of levodopa,carbidopa and entacapone (LCE) and will undergo brain imaging and 3) the 24 weeks outpatient treatment trial. The purpose is to see if treatment with LCE may reverse baseline brain deficits and if this change is associated with clinical improvement. Hypothesis is that treatment with LCE, compared to placebo, increases abstinence from cocaine over a 12-week trial in combination with behavioral treatment with voucher incentives.

Conditions

Cocaine Dependence

Keywords

cocaine dependence; levodopa; carbidopa; entacapone

Outcome Measures

Primary Outcomes (2)

• Cocaine Urine Toxicology

  Abstinence will be assessed by urine toxicology results collected 3x/week during the 24 week trial or for the length of participation

  collected 3x/week for 24 weeks of trial or for the duration of the participants involvement in the study.

• Retention in Treatment

  The number of participants who completed the 12-week medication phase of the study.

  12 weeks

Study Arms (2)

levodopa carbidopa and entacapone (LCE)

EXPERIMENTAL

400mg/100mg/200mg, twice daily dosing of levodopa carbidopa and entacapone (LCE)

Drug: levodopa carbidopa and entacapone (LCE)

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

levodopa carbidopa and entacapone (LCE) DRUG

400mg/100mg/200mg, twice daily

levodopa carbidopa and entacapone (LCE)

Placebo DRUG

matched placebo for LCE condition dosed twice daily

Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult, age 21-50.
• Meets DSM-IV criteria for current cocaine dependence, supported by a positive urine for cocaine metabolites
• Voluntarily seeking treatment for cocaine dependence
• Absence of other medical or psychiatric disorders that are unstable and would interfere with participation.
• Absence of any suspicious skin changes, suggestive of melanoma, during the full body exam
• Able to give informed consent.

You may not qualify if:

• Active psychiatric disorder which might interfere with participation or make participation hazardous, including DSM-IV organic mental disorder, psychotic disorder, bipolar disorder, recurrent severe MDD, OCD, or eating disorder. Participants with depressive disorder (provided that the score on the Hamilton Depression Scale is less than 20) and those with ADHD symptoms may be included, since these are common, often reflect effects of chronic drug use, and may improve with behavioral treatment and cessation or reduction of drug use.
• Unstable medical disorders, or medical disorders that might interfere with study participation, including seizure disorder.
• Significant current suicidal risk or 1 or more suicide attempts within the past year
• Concurrent treatment with psychotropic medications
• Positive serum pregnancy test, lactation, or unwillingness to use a satisfactory method of birth control
• Baseline systolic BP of \> 140 and \< 100, diastolic BP \> 90 and \< 60 and baseline HR greater than 90.
• Any clinically significant heart abnormality or cardiovascular disease
• History of glaucoma
• History of melanoma or current suspicious undiagnosed skin lesions
• History of allergic reaction or adverse reaction to study medications (levodopa/carbidopa/entacapone; methylphenidate; raclopride).
• 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" by Shellock
• Lifetime exposure to radiation in the workplace, or history of participation in nuclear medicine procedures, including research protocols
• Individuals who are predominantly left handed. Based on a score \<50 on the Edinburg Handed Inventory (E.H.I.).
• Adult, age 21-50.
• No current DSM-IV psychiatric or substance use disorders

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

STARS

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

carbidopa, levodopa drug combination; entacapone

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Adam Bisaga
• Organization: New York State Psychiatric Institute

bisagaa@nyspi.columbia.edu

646-774-6155

Study Officials

• Adam Bisaga, M.D.

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychiatrist

Study Record Dates

• First Submitted: November 7, 2011
• First Posted: November 9, 2011
• Study Start: July 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2015
• Last Updated: May 22, 2018
• Results First Posted: December 16, 2016

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)