Healthy VolunteersNCT01148381
Characterization of Phenotypic and Genotypic Regressors for Imaging
An observational study of Healthy Volunteers and Substance Use Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
The influence of genes on addictive and neuropsychiatric disorders is complex, especially given that multiple genes likely influence certain behaviors that are correlated with addiction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy Volunteers, Substance Use Disorders
- How many people
- 847 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2010to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: For the main study, subjects will be recruited from the pool of subjects who are being considered for other NIDA-IRP protocols. Therefore, participant distribution in the main study will reflect that specified in other NIDA-IRP protocols. No preferences in participant recruitment will be made on the basis of sex, race, or ethnic background. In both the main study and the CTN pilot, efforts will be made to include ethnic minorities in proportion to their presence in the Baltimore City area, which is where the majority of our subjects reside.
Who may be able to join
- All participants must be:
- -under evaluation for or enrolled in another NIDA-IRP study. Justification: This protocol is primarily meant to gather uniform characterization data on IRP participants although the data is useful regardless of participation in other protocols.
- ->= 18 years of age. Justification: The majority of NIDA-IRP studies only include adults, as such, we will only include adults in this study for now.
- All participants must:
- Either have a current DSM-5 diagnosis for at least one of the following substance use disorders: nicotine, cocaine, marijuana, opiate; or 2) no current DSM-5 substance use disorder (control participants). Justification: These criteria are consistent with the scope of this study to pilot this battery of tests for future use in similar populations enrolled in the NIDA CTN studies.
- Be >= 18 years of age. Justification: The NIDA CTN will use this battery in adults.
Who cannot join
- History of neurological illnesses that per the study clinicians would be significant enough to impair ability to tolerate the procedure or alter neuronal activity, including but not limited to CVA, CNS tumor, head trauma with significant sequelae, Multiple Sclerosis or other demyelinating diseases, epilepsy, movement disorders, or migraine in treatment. Assessment tool: History and physical (H\&P). Rationale: Neurological illnesses may impair ability to tolerate the procedures and alter neuronal activity, adding noise to the data.
- Cognitive impairment (unless this population of subjects is included in another IRP protocol for which the subject is also under consideration). Assessment tool: self-report during H\&P of special education classes, history of specific learning disability or mental retardation. A validated IQ test such as the Shipley-2 may also be administered. Rationale: Cognitive impairment may impair ability to tolerate the procedures and alter neuronal activity, adding noise to the data.
- Current major mood, anxiety or psychotic disorder (unless this population of subjects is included in another IRP protocol for which the subject is also under consideration). Assessment tool: self-report, H\&P, a structured or semi-structured psychiatric interview such as the computerized SCID with follow up clinical interview (or full interviewer-administered). Rationale: Current major mood or psychotic disorders may impair ability to tolerate the procedures and alter neuronal activity, adding noise to the data.
- Pregnancy. Assessment tool: Urine pregnancy test. Rationale: fMRI is not accepted as a safe procedure purely for research purposes during pregnancy.
- HIV -positive individuals. Assessment tool: oral HIV test with serum confirmation of positive results. Rationale: potential liver/metabolic/vascular disease can interfere with the physiological transduction mechanisms for fMRI (i.e. making the measurement unreliable).
- Unable to undergo MRI scanning due to possible pregnancy, metallic devices in the body, claustrophobia or body morphometry.
Show all 13Show fewer
- Currently using respiratory, cardiovascular or anticonvulsant medications that may interfere with the BOLD MRI signal.
- Non-English speaking. Assessment tool(s): self-report. Rationale: To include non-English speakers, we would have to translate the consent and other study documents and hire and train bilingual staff, which would require resources that we do not have and could not justify given the small sample size for each experiment. Additionally, the data integrity of some of the cognitive tasks and standardized questionnaires used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing study procedures. The inability to effectively communicate safety procedures in a language other than English could compromise the safety of non-English speaking participants.
- Other health conditions that would impact safety of participation or scientific integrity of data collection.
- A DSM-5 major psychiatric diagnoses unrelated to a substance use disorder including but not limited to bipolar disorder and schizophrenia. Diagnoses secondary to substance use disorder will be allowable providing the participant's symptoms do not interfere with the ability to complete assessments. Assessment tool: self-report, H\&P, structured or semi-structured psychiatric interview.
- Rationale: Current major mood or psychotic disorders may impair ability to complete the assessments and would add unnecessary noise to the data.
- Cognitive impairment. Assessment tool: self-report during H\&P of special education classes, history of specific learning disability or mental retardation. A validated IQ test such as the Shipley-2 may also be administered. Rationale: Cognitive impairment may impair ability to complete the assessments and would add unnecessary noise to the data.
- Non-English speaking. Assessment tool(s): self-report. Rationale: To include non-English speakers, we would have to translate the consent and other study documents and hire and train bilingual staff, which would require resources that we do not have and could not justify given the small sample size for each experiment. Additionally, the data integrity of some of the cognitive tasks and standardized questionnaires used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing study procedures. The inability to effectively communicate safety procedures in a language other than English could compromise the safety of non-English speaking participants.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Drug Abuse, Biomedical Research Center (BRC)
Baltimore, Maryland, 21224
About this study
Official title: Characterization of Phenotypic and Genotypic Regressors
The influence of genes on addictive and neuropsychiatric disorders is complex, especially given that multiple genes likely influence certain behaviors that are correlated with addiction. Researchers are interested in looking at the genetic information of individuals who are enrolled on National Institute for Drug Abuse studies to investigate specific genetic variants that may be related to substance abuse. Researchers will study the effects of genes on several aspects of thinking such as attention, memory, decision making, problem solving, learning, and emotional feelings, and investigate the ways in which genetic information affects addictive behaviors and substance abuse. In addition, researchers will study how genes may explain differences in imaging data in substance users.
Objectives:
Read more
- To collect genetic information for research on genetic aspects of addiction and substance abuse.
Eligibility:
- Adults age 18 or older
- (1) healthy, non-drug-using nonsmokers,
- (2) healthy smokers,
- (3) healthy individuals dependent on other commonly abused drugs, and
- (4) individuals with other psychiatric disorders.
- Participants must be enrolled in another National Institute on Drug Abuse, Intramural Research Program imaging protocol.
Design:
- This study involves one to two visits to National Institute on Drug Abuse, Intramural Research Program that may be separate from the participant's current research protocol study visits or on the same day as those visits.
- Participants will provide a blood sample and complete questionnaires about mood, memory, and learning.
- Participants may also be asked to do a few tasks, such as playing computer games involving coin tosses and money management, or responding to questions on a computer screen.
Read the detailed description
Objective: To determine genetic variants as well as behavioral measures across different study group populations. Results of these will be used as regressors to help explain inter-individual differences in data collected across IRP protocols.
Study Population: The study population will include 1) healthy non-smoking, participants with no substance use disorders 2) healthy individuals with nicotine use disorder 3) healthy individuals with other substance use disorders 4) individuals with other psychiatric disorders and 5) treatment-seeking individuals with substance use disorders. Participants must be under evaluation for another NIDA-IRP protocol, generally healthy, and age 18 or older.
Design: The main study will require approximately 5-8 hours. Main study procedures may be done in 1 visit or multiple visits, and may be done in conjunction with another NIDA-IRP study. After being consented into the main study, the participant will be asked to submit a blood sample, an MRI scan, complete various questionnaires, characterization instruments and several behavioral tasks. Blood will only be drawn once, provided there are no technical problems (such as sample damage during collection, preparation, shipping or assay) requiring a repeat draw. If participants enroll in other NIDA-IRP imaging protocols, they will be asked to repeat a few of the time- sensitive questionnaires in this protocol during the MRI visits of the other protocols. Data acquired in this protocol will be compared to data acquired in other NIDA-IRP protocols.
An arm of this protocol will be used to pilot test a phenotyping battery developed by the NIDA CTN. This battery overlaps with several of the assessments in the main protocol. Participants in the NIDA CTN pilot study who also meet criteria for the main study may participate in the main study as well. The CTN Pilot procedures require approximately 4-6 hours to complete.
Outcome Measures: The primary outcome measures in this study are the genetic, behavioral and phenotypic factors that are related to addiction. Secondary outcome measures are to compare the genetic, behavioral and phenotypic factors to imaging and behavioral data acquired across other IRP protocols.
- Conditions
- Healthy Volunteers, Substance Use Disorders
- Keywords
- Genotype, Phenotype, Characterization, fMRI, Natural History
- Medical subject headings
- Substance-Related Disorders
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 |
|---|---|---|
| controls | healthy non-smoking, participants with no substance use disorders | |
| psychiatric disorders | individuals with other psychiatric disorders | |
| smokers | healthy individuals with nicotine use disorder | |
| substance use disorders | healthy individuals with other substance use disorders | |
| treatment seeking individuals | treatment seeking individuals with substance use disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measures are the genetic, behavioral and phenotypic factors that are related to addiction.
To determine whether genetic polymorphisms, phenotypic measures and behavioral characterization instruments can explain variance in structural and functional imaging data and in behavioral outcome measures such as treatment outcome or substance use trajectories or patterns as collected under other NIDA IRP protocols and clinical trials conducted in the NIDA CTN.
Measured: each visit
Secondary outcomes (1)
Secondary outcome measures are to compare the genetic, behavioral and phenotypic factors to imaging and behavioral data acquired across other IRP protocols.
To compare the genetic, behavioral and phenotypic factors to imaging and behavioral data acquired across other IRP protocols
Measured: each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study start18 Nov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 847 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Amy C Janes, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148381
- Sponsor's protocol ID
- 999910457
- Other IDs
- 10-DA-N457
- Status last verified
- 9 Sep 2026
- First submitted
- 19 Jun 2010
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Phenotypic and Genotypic Regressors
- ClinicalTrials.gov ID
- NCT01148381
- Acronym / sponsor ID
- 999910457
- Conditions
- Healthy Volunteers, Substance Use Disorders
- Keywords
- Genotype, Phenotype, Characterization, fMRI, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 847 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 18 Nov 2010 (actual)
- First posted
- 22 Jun 2010 (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 influence of genes on addictive and neuropsychiatric disorders is complex, especially given that multiple genes likely influence certain behaviors that are correlated with addiction. Researchers are interested in looking at the genetic information of individuals who are enrolled on National Institute for Drug Abuse studies to investigate specific genetic variants that may be related to substance abuse. Researchers will study the effects of genes on several aspects of thinking such as attention, memory, decision making, problem solving, learning, and emotional feelings, and investigate the ways in which genetic information affects addictive behaviors and substance abuse. In addition, researchers will study how genes may explain differences in imaging data in substance users.
Objectives:
- To collect genetic information for research on genetic aspects of addiction and substance abuse.
Eligibility:
- Adults age 18 or older
- (1) healthy, non-drug-using nonsmokers,
- (2) healthy smokers,
- (3) healthy individuals dependent on other commonly abused drugs, and
- (4) individuals with other psychiatric disorders.
- Participants must be enrolled in another National Institute on Drug Abuse, Intramural Research Program imaging protocol.
Design:
- This study involves one to two visits to National Institute on Drug Abuse, Intramural Research Program that may be separate from the participant's current research protocol study visits or on the same day as those visits.
- Participants will provide a blood sample and complete questionnaires about mood, memory, and learning.
- Participants may also be asked to do a few tasks, such as playing computer games involving coin tosses and money management, or responding to questions on a computer screen.
Detailed description
Objective: To determine genetic variants as well as behavioral measures across different study group populations. Results of these will be used as regressors to help explain inter-individual differences in data collected across IRP protocols.
Study Population: The study population will include 1) healthy non-smoking, participants with no substance use disorders 2) healthy individuals with nicotine use disorder 3) healthy individuals with other substance use disorders 4) individuals with other psychiatric disorders and 5) treatment-seeking individuals with substance use disorders. Participants must be under evaluation for another NIDA-IRP protocol, generally healthy, and age 18 or older.
Design: The main study will require approximately 5-8 hours. Main study procedures may be done in 1 visit or multiple visits, and may be done in conjunction with another NIDA-IRP study. After being consented into the main study, the participant will be asked to submit a blood sample, an MRI scan, complete various questionnaires, characterization instruments and several behavioral tasks. Blood will only be drawn once, provided there are no technical problems (such as sample damage during collection, preparation, shipping or assay) requiring a repeat draw. If participants enroll in other NIDA-IRP imaging protocols, they will be asked to repeat a few of the time- sensitive questionnaires in this protocol during the MRI visits of the other protocols. Data acquired in this protocol will be compared to data acquired in other NIDA-IRP protocols.
An arm of this protocol will be used to pilot test a phenotyping battery developed by the NIDA CTN. This battery overlaps with several of the assessments in the main protocol. Participants in the NIDA CTN pilot study who also meet criteria for the main study may participate in the main study as well. The CTN Pilot procedures require approximately 4-6 hours to complete.
Outcome Measures: The primary outcome measures in this study are the genetic, behavioral and phenotypic factors that are related to addiction. Secondary outcome measures are to compare the genetic, behavioral and phenotypic factors to imaging and behavioral data acquired across other IRP protocols.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| controls | – | –healthy non-smoking, participants with no substance use disorders |
| psychiatric disorders | – | –individuals with other psychiatric disorders |
| smokers | – | –healthy individuals with nicotine use disorder |
| substance use disorders | – | –healthy individuals with other substance use disorders |
| treatment seeking individuals | – | –treatment seeking individuals with substance use disorders |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For the main study, subjects will be recruited from the pool of subjects who are being considered for other NIDA-IRP protocols. Therefore, participant distribution in the main study will reflect that specified in other NIDA-IRP protocols. No preferences in participant recruitment will be made on the basis of sex, race, or ethnic background. In both the main study and the CTN pilot, efforts will be made to include ethnic minorities in proportion to their presence in the Baltimore City area, which is where the majority of our subjects reside.
Key inclusion criteria (6 listed)
- -under evaluation for or enrolled in another NIDA-IRP study. Justification: This protocol is primarily meant to gather uniform characterization data on IRP participants although the data is useful regardless of participation in other protocols.
- ->= 18 years of age. Justification: The majority of NIDA-IRP studies only include adults, as such, we will only include adults in this study for now.
- Either have a current DSM-5 diagnosis for at least one of the following substance use disorders: nicotine, cocaine, marijuana, opiate; or 2) no current DSM-5 substance use disorder (control participants). Justification: These criteria are consistent with the scope of this study to pilot this battery of tests for future use in similar populations enrolled in the NIDA CTN studies.
- Be >= 18 years of age. Justification: The NIDA CTN will use this battery in adults.
Key exclusion criteria (13 listed)
- History of neurological illnesses that per the study clinicians would be significant enough to impair ability to tolerate the procedure or alter neuronal activity, including but not limited to CVA, CNS tumor, head trauma with significant sequelae, Multiple Sclerosis or other demyelinating diseases, epilepsy, movement disorders, or migraine in treatment. Assessment tool: History and physical (H\&P). Rationale: Neurological illnesses may impair ability to tolerate the procedures and alter neuronal activity, adding noise to the data.
- Cognitive impairment (unless this population of subjects is included in another IRP protocol for which the subject is also under consideration). Assessment tool: self-report during H\&P of special education classes, history of specific learning disability or mental retardation. A validated IQ test such as the Shipley-2 may also be administered. Rationale: Cognitive impairment may impair ability to tolerate the procedures and alter neuronal activity, adding noise to the data.
- Current major mood, anxiety or psychotic disorder (unless this population of subjects is included in another IRP protocol for which the subject is also under consideration). Assessment tool: self-report, H\&P, a structured or semi-structured psychiatric interview such as the computerized SCID with follow up clinical interview (or full interviewer-administered). Rationale: Current major mood or psychotic disorders may impair ability to tolerate the procedures and alter neuronal activity, adding noise to the data.
- Pregnancy. Assessment tool: Urine pregnancy test. Rationale: fMRI is not accepted as a safe procedure purely for research purposes during pregnancy.
- HIV -positive individuals. Assessment tool: oral HIV test with serum confirmation of positive results. Rationale: potential liver/metabolic/vascular disease can interfere with the physiological transduction mechanisms for fMRI (i.e. making the measurement unreliable).
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
The primary outcome measures are the genetic, behavioral and phenotypic factors that are related to addiction.
Time frame: each visit
To determine whether genetic polymorphisms, phenotypic measures and behavioral characterization instruments can explain variance in structural and functional imaging data and in behavioral outcome measures such as treatment outcome or substance use trajectories or patterns as collected under other NIDA IRP protocols and clinical trials conducted in the NIDA CTN.
1 secondary outcome
Secondary outcome measures are to compare the genetic, behavioral and phenotypic factors to imaging and behavioral data acquired across other IRP protocols.
Time frame: each visit
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 8 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Screening Protocol
Pain
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.
Amy C Janes, Ph.D. principal investigator
National Institute on Drug Abuse (NIDA)
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 Healthy Volunteers and Substance Use Disorders, run by National Institute on Drug Abuse (NIDA) 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 6 inclusion and 13 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 8 Oct 2026. 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?
The primary outcome measures are the genetic, behavioral and phenotypic factors that are related to addiction. (time frame: each visit). 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 8 Oct 2026.