Cocaine-Related DisordersNCT00430690
Acoustic Startle Reduction In Cocaine Dependence
An observational study of Cocaine-Related Disorders, run by Emory University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine-Related Disorders
- What is being tested?
- acoustic startle testing
- Type of treatment
- Surgery or procedure
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to 19 Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with cocaine dependence who are entering substance abuse treatment; siblings of these subjects; and healthy controls
Who may be able to join
- Cocaine dependent subjects:
- males or females,
- age 18-80,
- with a DSM-IV diagnosis of cocaine dependence,
- 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.
Who cannot join
- current clinically significant medical illness (including HIV, because of possible confound of neurological involvement),
- 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,
- other Axis I psychiatric disorder currently or in the previous three months with the exception of substance induced disorders as determined by SCID,
- history of schizophrenia, schizoaffective disorder, posttraumatic stress disorder, or bipolar disorder,
- known hearing impairments (intact hearing will be insured by brief audiology screening),
- dependence on other drugs or alcohol within the previous 6 months, as confirmed by ASI.
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- Healthy controls:
- males or females,
- age 18-80.
- history of any Axis I psychiatric illness or history of treatment as determined by SCID Axis I,
- substance dependence or abuse history by ASI and SCID,
- no current clinically significant medical illness (including HIV),
- 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,
- known hearing impairments (intact hearing will be insured by brief audiology screening),
- Axis I disorder, including substance dependence, in first degree family member.
- Family members of cocaine subjects:
- males or females,
- age 18-80,
- family member of cocaine-dependent subject enrolled in study.
- history of any Axis I psychiatric illness or history of treatment as determined by SCID Axis I,
- substance dependence history by ASI and SCID, or substance abuse within the prior 5 years,
- no current clinically significant medical illness (including HIV),
- current or past neurological illness, or history of head trauma with loss of consciousness,
- known hearing impairments
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlanta Veterans Adminstration Medical Center
Decatur, Georgia, 30033
About this study
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.
- Conditions
- Cocaine-Related Disorders
- Being tested
- acoustic startle testing
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acoustic startle testingProcedure or surgery
acoustic startle testing: listening to sounds through headphones while the eyeblink component of the acoustic startle reflex is recorded with small surface electrodes
| Study group | Role | What they receive |
|---|---|---|
| 1 | Cocaine dependent subjects Receives: Procedure: acoustic startle testing | |
| 2 | Healthy controls Receives: Procedure: acoustic startle testing | |
| 3 | Siblings of cocaine dependent subjects Receives: Procedure: acoustic startle testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acoustic startle magnitude
Magnitude of acoustic startle response as measured by electromyography of eyeblink.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2007 (estimated)
- Study startSep 2006
- Primary completion19 Jul 2011
- Study completion19 Jul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine-Related DisordersStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Erica Duncan, MD, Emory University
- Investigators
- Erica Duncan, MD, Principal investigator, Emory University / Atlanta VA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430690
- Sponsor's protocol ID
- IRB00002489
- Other IDs
- R01DA018294-01A2
- Status last verified
- Aug 2019
- First submitted
- 1 Feb 2007
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acoustic Startle Reduction In Cocaine Dependence
- ClinicalTrials.gov ID
- NCT00430690
- Acronym / sponsor ID
- IRB00002489
- Conditions
- Cocaine-Related Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2006 (actual)
- Primary completion
- 19 Jul 2011 (actual)
- Study completion
- 19 Jul 2011 (actual)
- First posted
- 2 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: acoustic startle testingCocaine dependent subjects |
| 2 | – | Procedure: acoustic startle testingHealthy controls |
| 3 | – | Procedure: acoustic startle testingSiblings of cocaine dependent subjects |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with cocaine dependence who are entering substance abuse treatment; siblings of these subjects; and healthy controls
Key inclusion criteria (5 listed)
- males or females,
- age 18-80,
- with a DSM-IV diagnosis of cocaine dependence,
- 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.
Key exclusion criteria (24 listed)
- current clinically significant medical illness (including HIV, because of possible confound of neurological involvement),
- 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,
- other Axis I psychiatric disorder currently or in the previous three months with the exception of substance induced disorders as determined by SCID,
- history of schizophrenia, schizoaffective disorder, posttraumatic stress disorder, or bipolar disorder,
- known hearing impairments (intact hearing will be insured by brief audiology screening),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acoustic startle testingacoustic startle testing: listening to sounds through headphones while the eyeblink component of the acoustic startle reflex is recorded with small surface electrodes | Procedure or surgery | 1, 2, 3 |
Primary outcome
Acoustic startle magnitude
Time frame: at baseline
Magnitude of acoustic startle response as measured by electromyography of eyeblink.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica Duncan, MD principal investigator
Emory University / Atlanta VA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cocaine-Related Disorders, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acoustic startle magnitude (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019; AzTrials last refreshed its copy on 1 Nov 2026.