Acoustic Startle Reduction In Cocaine Dependence

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Erica Duncan, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00430690
First received: February 1, 2007
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

Chronic cocaine administration leads to changes in brain function that persist long after the acute withdrawal phase. The acoustic startle response (ASR) is a well characterized reflexive response to a sudden acoustic stimulus. The ASR is mediated by a simple 3-synapse subcortical circuit; it is modulated in part by brain areas and neurotransmitters associated with cocaine administration. Our initial study and subsequent replication reveals a profound diminution of the ASR in cocaine-dependent subjects after a brief period of abstinence. Our preliminary findings indicate that first degree relatives of cocaine-dependent subjects also have reduced startle compared to healthy controls. The findings of low ASR in rats and humans during cocaine washout and low ASR in family members suggests there may be both a trait and state component of the startle reductions we have reported.

The central objectives of this proposal are to dissect this finding with regard to its development and persistence in early and later phases of cocaine abstinence in humans; to ascertain whether startle reduction and its potential normalization during later abstinence is a predictor of clinical course in human subjects with cocaine dependence; and to examine whether startle reduction is, at least in part, a vulnerability trait for the development of cocaine dependence. This latter Aim will be carried out in humans by testing siblings of cocaine-dependent subjects.

Cocaine dependence is an enormous public health problem. The significance of this work lies in the potential for the ASR reduction to serve as a reliable, easily repeatable biological measure of cocaine-induced brain changes that may enhance outcome prediction so that tailored treatments may be directed at those patients most vulnerable to relapse, given the restriction of resources for available for substance abuse treatment.


Condition Intervention
Cocaine-Related Disorders
Procedure: acoustic startle testing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acoustic Startle Reduction In Cocaine Dependence

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • acoustic startle magnitude [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    Magnitude of acoustic startle response as measured by electromyography of eyeblink.


Biospecimen Retention:   Samples With DNA

Blood and extracted DNA


Estimated Enrollment: 135
Study Start Date: September 2006
Estimated Study Completion Date: December 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Cocaine dependent subjects
Procedure: acoustic startle testing
acoustic startle testing: listening to sounds through headphones while the eyeblink component of the acoustic startle reflex is recorded with small surface electrodes
2
Healthy controls
Procedure: acoustic startle testing
acoustic startle testing: listening to sounds through headphones while the eyeblink component of the acoustic startle reflex is recorded with small surface electrodes
3
Siblings of cocaine dependent subjects
Procedure: acoustic startle testing
acoustic startle testing: listening to sounds through headphones while the eyeblink component of the acoustic startle reflex is recorded with small surface electrodes

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Subjects with cocaine dependence who are entering substance abuse treatment; siblings of these subjects; and healthy controls

Criteria

Inclusion Criteria:

Cocaine dependent subjects:

  1. males or females,
  2. age 18-80,
  3. with a DSM-IV diagnosis of cocaine dependence,
  4. a usage history characterized by a minimum of 1 year of at least $50 per day or weekly binges of at least $200 of cocaine use.

Exclusion Criteria:

  1. current clinically significant medical illness (including HIV, because of possible confound of neurological involvement),
  2. current or past neurological illness, and no history of head trauma with loss of consciousness ≥ 5 minutes because of the possible confound of neurological damage to startle-modulating brain areas,
  3. other Axis I psychiatric disorder currently or in the previous three months with the exception of substance induced disorders as determined by SCID,
  4. history of schizophrenia, schizoaffective disorder, posttraumatic stress disorder, or bipolar disorder,
  5. known hearing impairments (intact hearing will be insured by brief audiology screening),
  6. dependence on other drugs or alcohol within the previous 6 months, as confirmed by ASI.

Healthy controls:

  1. males or females,
  2. age 18-80.

Exclusion criteria:

  1. history of any Axis I psychiatric illness or history of treatment as determined by SCID Axis I,
  2. substance dependence or abuse history by ASI and SCID,
  3. no current clinically significant medical illness (including HIV),
  4. current or past neurological illness, or history of head trauma with loss of consciousness ≥ 5 minutes because of the possible confound of neurological damage to startle-modulating brain areas,
  5. known hearing impairments (intact hearing will be insured by brief audiology screening),
  6. Axis I disorder, including substance dependence, in first degree family member.

Family members of cocaine subjects:

  1. males or females,
  2. age 18-80,
  3. family member of cocaine-dependent subject enrolled in study.

Exclusion criteria:

  1. history of any Axis I psychiatric illness or history of treatment as determined by SCID Axis I,
  2. substance dependence history by ASI and SCID, or substance abuse within the prior 5 years,
  3. no current clinically significant medical illness (including HIV),
  4. current or past neurological illness, or history of head trauma with loss of consciousness,
  5. known hearing impairments
  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: NCT00430690

Locations
United States, Georgia
Atlanta Veterans Adminstration Medical Center
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Erica Duncan, MD Emory University / Atlanta VA
  More Information

No publications provided

Responsible Party: Erica Duncan, MD, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00430690     History of Changes
Other Study ID Numbers: IRB00002489, RO1 DA018294-01A2
Study First Received: February 1, 2007
Last Updated: November 13, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Cocaine
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 28, 2014