Modafinil, DRD4 Genotype and Cocaine Relapse

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by New York State Psychiatric Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01778010
First received: January 24, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

Treatment for cocaine dependence is characterized by high rates of relapse, yet the factors influencing the likelihood of relapse are poorly understood. Exposure to cocaine, stress and cocaine-related cues increase cocaine craving, and genetic polymorphisms in the dopamine D4 receptor subtype (DRD4) influence the effects of cues and drug exposure on ratings of craving. However, craving does not robustly predict drug use or relapse. There are currently no data characterizing the interaction between DRD4 polymorphisms, cues and cocaine exposure on actual cocaine taking, i.e., cocaine self-administration. Incorporating measures of relapse into our established laboratory model is an important objective for medications development because models of cocaine self-administration have predictive validity in screening medications for cocaine dependence. Aim 1: Refine our cocaine self-administration procedures to include measures of relapse. The model is guided by hypotheses supported by pilot data: The likelihood of relapse and the quantity of cocaine self-administered following relapse will vary as a function of (1) the cost of cocaine, (2) the presence of contextual cues associated with cocaine-taking, and (3) noncontingent cocaine administration (i.e., 'priming'). Aim 2: Determine the influence of DRD4 polymorphisms on cue- and cocaine-induced relapse. Data with alcohol have demonstrated that individuals heterozygous or homozygous for 7 or more allele repeats (DRD4L) show increased cue- and alcohol-induced craving and greater relapse clinically than those with fewer than 7 allele repeats (DRD4 S). We hypothesize that cocaine-dependent DRD4 L volunteers will show greater cue- and prime-induced relapse compared to the DRD4 S group. Aim 3: Test the effects of modafinil on measures of cocaine relapse as a function of DRD4 polymorphisms. We hypothesize that modafinil will: (1) decrease the effect of both cues and a cocaine prime on the likelihood of relapse compared to placebo, (2) decrease the amount of cocaine self-administered if cocaine use is initiated, and (3) be more effective decreasing cue-and cocaine-induced relapse in the DRD4 L group than the DRD4 S group.

This study will provide valuable information about the interaction between genetic variability, modafinil and environmental factors believed to increase cocaine relapse.


Condition Intervention Phase
Cocaine Dependence
Drug: Modafinil
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Modafinil and DRD4 Genotype in a Human Laboratory Model of Cocaine Relapse

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Cocaine self-administration [ Time Frame: Four years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: placebo, modafinil
Modafinil (150 mg bid) or placebo for 21 days.
Drug: Modafinil
Modafinil (300 mg) administration for 3 weeks
Other Name: Provigil
Drug: Modafinil
Modafinil (300 mg/day) for 3 weeks
Other Name: Provigil

Detailed Description:

Provide a more extensive description, if desired. I do not desire to.

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Smokes cocaine
  2. Has patterns of smoked cocaine use in terms of frequency and amount which parallel or exceed those administered in the study.
  3. Age 21-50.
  4. Able to give informed consent, and comply with study procedures.
  5. Normal body weight Within normal weight range (for appropriate frame) according to 1983 Metropolitan Weight tables -

Exclusion Criteria:

  1. Current seizure disorder, heart disease or a history of serious adverse effects due to cocaine.
  2. Dependence on substances (other than cocaine or nicotine) or a history of dependence on alcohol
  3. Request for drug treatment
  4. Judged to be noncompliant with study protocol.
  5. Current use of any psychotropic medication.
  6. Clinical laboratory tests outside normal limits that are clinically unacceptable to the study physician (BP > 140/90; BUN, creatinine, LFTs > 3x ULN; hematocrit < 34 for women, < 36 for men; pseudocholinesterase deficiency)
  7. History of myocardial infarction or ischemia, clinically significant left ventricular hypertrophy, angina, clinically significant arrhythmia, or mitral valve prolapse
  8. Currently meeting DSM-IV criteria for all major psychiatric/psychotic disorders other than transient psychosis due to drug abuse
  9. Current parole or probation Self-report during intervie -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01778010

Contacts
Contact: Nicholas Urban 212 305 4970

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Mal Zawanda    212-305-4970      
Principal Investigator: Margaret Haney, Ph.D.         
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Margaret Haney, Ph.D. NYS Psychiatric Institute
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01778010     History of Changes
Other Study ID Numbers: 5738, R01DA023650
Study First Received: January 24, 2013
Last Updated: January 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by New York State Psychiatric Institute:
cocaine
modafinil
self-administration
DRD4

Additional relevant MeSH terms:
Cocaine
Modafinil
Armodafinil
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Wakefulness-Promoting Agents
Central Nervous System Stimulants

ClinicalTrials.gov processed this record on October 02, 2014