Cocaine DependenceNCT01558973
FMRI of Stress and Addictive Disorders
An observational study of Cocaine Dependence and Opioid Dependence, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to explore whether frontal brain activation in response to stress varies as a function of the presence or extent of early trauma and whether or not this effect is greater in women compared to men. To examine the effect of stress on thinking and remembering. Read more about this study
- Who is it for?
- Ages 13 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine Dependence, Opioid Dependence, Alcoholism
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Dec 2015
- 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 13 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Cocaine dependent individuals, opioid dependent individuals, alcohol dependent individuals, healthy controls, adolescent subjects, pathological gamblers
Who may be able to join
- Between ages 13-50 years old (adolescents 13-17 years old)
- Able to read and write.
- COCAINE DEPENDENT SUBJECTS: meet DSM-IV criteria for cocaine dependence; report current cocaine use of at least once a week or more; confirmation of cocaine use via positive urine toxicology screen during initial assessments and upon admission to the CNRU.
- OPIOID DEPENDENT SUBJECTS: meet DSM-IV criteria for opiate dependence and are participating in substance abuse treatment including pharmacotherapy for opioid dependence.
- ALCOHOL DEPENDENT SUBJECTS: meet DSM-IV criteria for alcohol dependence and are currently abstinent from alcohol as documented by substance abuse treatment participation.
- HEALTHY CONTROLS: negative urine toxicology screens during intake appointments indicating no history of current or past dependence on alcohol or illicit drug use.
- Healthy adolescent boys and girls, with no medical or psychiatric conditions;
- WOMEN: have a regular menstrual cycle.
Who cannot join
- CONTROLS: lifetime or current history of any substance abuse/dependence (excluding nicotine).
- Regular use of any psychoactive drugs including anxiolytics and antidepressants.
- Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, liver, thyroid pathology; subjects on medications for any medical condition will be excluded.
- Any subjects with foreign ferromagnetic metal objects in their body or other MR contraindications will be excluded including subjects who work as welders.
- Women on oral contraceptives, peri- and post-menopausal women, and pregnant or lactating women (as alterations in stress response are associated with these states).
- IQ below 75
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Magnetic Resonance Imaging of Stress and Addictive Disorders
The purpose of this study is to explore whether frontal brain activation in response to stress varies as a function of the presence or extent of early trauma and whether or not this effect is greater in women compared to men. To examine the effect of stress on thinking and remembering. To examine the separate and interactive effects of stress, addiction, withdrawal, and genetics; and to examine fMRI brain activation associated with stressful, reward-related-cue and neutral/relaxing audiotaped scripts,visual images and emotional video clips in addicted individuals and in healthy controls.
- Medical subject headings
- Cocaine-Related Disorders, Opioid-Related Disorders, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cocaine dependent | Not described | |
| Opioid dependent | Not described | |
| Alcohol dependent | Not described | |
| Healthy controls | Not described | |
| Adolescents | Not described | |
| Pathological gamblers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural responses to change will be measured.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startAug 2005
- Primary completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- More trials run by Yale 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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Rajita Sinha, Yale University
- Investigators
- Rajita Sinha, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558973
- Sponsor's protocol ID
- 0405026787
- Other IDs
- 2P50DA016556-08
- Status last verified
- Nov 2016
- First submitted
- 18 Mar 2012
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Magnetic Resonance Imaging of Stress and Addictive Disorders
- ClinicalTrials.gov ID
- NCT01558973
- Acronym / sponsor ID
- 0405026787
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- Aug 2005
- Primary completion
- Dec 2015 (actual)
- First posted
- 20 Mar 2012 (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.
The purpose of this study is to explore whether frontal brain activation in response to stress varies as a function of the presence or extent of early trauma and whether or not this effect is greater in women compared to men. To examine the effect of stress on thinking and remembering. To examine the separate and interactive effects of stress, addiction, withdrawal, and genetics; and to examine fMRI brain activation associated with stressful, reward-related-cue and neutral/relaxing audiotaped scripts,visual images and emotional video clips in addicted individuals and in healthy controls.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cocaine dependent | – | – |
| Opioid dependent | – | – |
| Alcohol dependent | – | – |
| Healthy controls | – | – |
| Adolescents | – | – |
| Pathological gamblers | – | – |
Who may qualify
- Ages
- 13 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Cocaine dependent individuals, opioid dependent individuals, alcohol dependent individuals, healthy controls, adolescent subjects, pathological gamblers
Key inclusion criteria (8 listed)
- Between ages 13-50 years old (adolescents 13-17 years old)
- Able to read and write.
- COCAINE DEPENDENT SUBJECTS: meet DSM-IV criteria for cocaine dependence; report current cocaine use of at least once a week or more; confirmation of cocaine use via positive urine toxicology screen during initial assessments and upon admission to the CNRU.
- OPIOID DEPENDENT SUBJECTS: meet DSM-IV criteria for opiate dependence and are participating in substance abuse treatment including pharmacotherapy for opioid dependence.
- ALCOHOL DEPENDENT SUBJECTS: meet DSM-IV criteria for alcohol dependence and are currently abstinent from alcohol as documented by substance abuse treatment participation.
Key exclusion criteria (6 listed)
- CONTROLS: lifetime or current history of any substance abuse/dependence (excluding nicotine).
- Regular use of any psychoactive drugs including anxiolytics and antidepressants.
- Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, liver, thyroid pathology; subjects on medications for any medical condition will be excluded.
- Any subjects with foreign ferromagnetic metal objects in their body or other MR contraindications will be excluded including subjects who work as welders.
- Women on oral contraceptives, peri- and post-menopausal women, and pregnant or lactating women (as alterations in stress response are associated with these states).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neural responses to change will be measured.
Time frame: Baseline
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 30 Nov 2016.
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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.
Rajita Sinha, PhD principal investigator
Yale University
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 Dependence and Opioid Dependence, run by Yale 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 8 inclusion and 6 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 30 Nov 2016. 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?
Neural responses to change will be measured. (time frame: 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 30 Nov 2016.