Drug AddictionNCT01621607
Individual Differences in Reward and Impulse Control
An observational study of Drug Addiction and Vulnerability to Substance Addiction, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Background: The risk for becoming addicted to drugs varies among individual, even those using similar drugs in a similar way. It is not known why some people become addicted and others do not. Studies suggest that some genes may increase the risk of addiction. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Addiction, Vulnerability to Substance Addiction
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2012to 3 Oct 2017
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18 and 55 years old (inclusive);
- Must be able to provide informed consent;
- Blood pressure (BP) and heart rate (HR) while sitting at or below the following values after five min rest: Systolic BP (SBP) 140 mm Hg, diastolic BP (DBP) 90 mm Hg, heart rate (HR) 100 bpm;
- No history of placement in special-education classes as a consequence of serious learning problems (to be assessed during the History and Physical assessment).
- Right-handed (based on Edinburgh Handedness Inventory);
- Eligible to enter the MRI scanner, as determined though self report on the MRI screening form (from the screening protocol 06-DA-N415).
Show all 11Show fewer
- Smoked for at least 2 years, and has generally smoked 10 cpd in the past year and consistently for the past 30 days.
- Be able to refrain from smoking for up to 4hrs during the study.
- Carry 2 or more plasticity alleles (assessed through protocol # 10-DA-N457 or other IRP protocols)
- Not have a history of daily cigarette smoking lasting more than a month and no smoking within the past 2 years.
- Carry 2 or more plasticity alleles (assessed through protocol # 10-DA-N457 or other IRP protocols)
Who cannot join
- Report of a history of significant medical/neurological illness that might interfere with imaging data such as HIV positive status, cerebral vascular accident (CVA), central nervous system (CNS) tumor, traumatic brain injury, multiple sclerosis (MS) or other demyelinating diseases, epilepsy, or movement disorders;
- History of psychosis or any current DSM-IV axis I disorder (other than simple phobia);
- Current use of psychotropic medication that may alter attentional functioning (e.g., Clonidine, antipsychotics, Venlafaxine, stimulants);
- Current use of substances on the study visit that might influence performance on tasks as assessed by self-report, carbon monoxide (CO) monitoring, alcohol breathalyzer and urine testing; (and neuromotor evaluation, when needed). If participant is intoxicated at the time of the study visit; he/she will be rescheduled for a later visit.
- Meets criteria for abuse, or DSM-IV dependence, or dependence in partial remission, on any drug except nicotine. Past abuse of marijuana or alcohol is acceptable provided it is at least 1 year in the past.
- Pregnancy, which will be assessed by history during screening and by urine testing on scan days;
- Claustrophobia by self report, or through response to the mock-scanner environment, severe enough to preclude toleration of the scanning environment.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Drug Abuse
Baltimore, Maryland, 21224
About this study
Official title: Gene x Environment Interactions as Risk Factors for Addiction
Background:
- The risk for becoming addicted to drugs varies among individual, even those using similar drugs in a similar way. It is not known why some people become addicted and others do not. Studies suggest that some genes may increase the risk of addiction. Negative life experiences may also affect the risk of addiction. Researchers want to test smokers and nonsmokers to study genetic and brain function traits that may lead to drug addiction.
Read more
Objectives:
- To understand brain function in people who may be at a higher risk of drug addiction.
Eligibility:
- Healthy volunteers between 18 and 55 years of age.
- Smokers (10 to 30 cigarettes per day for more than 2 years) and nonsmokers will be eligible.
Design:
- Participants will be screened with a physical exam and medical history. They will be tested for drug and alcohol use. A blood sample will be collected.
- The study will involve one visit. Participants will have a magnetic resonance imaging (MRI) scan.
- At the visit, participants will answer questions about their health and drug use habits. They will then be trained on the tasks they will do during the MRI scan. After the training, they will have the scan and perform the tasks. The scan and tasks will look at brain function related to rewards and impulsiveness.
- Other computer tests will be given after the scan. These tests will measure learning, memory, and impulsiveness.
Read the detailed description
Background: Even under similar drug use patterns, the risk for drug addiction varies from individual to individual. However, the neurobiological mechanisms underlying this variability are poorly understood and characterized. Studies suggest that certain traits observed in substance dependent individuals may actually precede drug use, and could augur future substance dependence. Understanding how the presence of these traits increases vulnerability to substance addiction could aid in the development of early intervention, preventative measures, as well as better treatment strategies.
Objective: The primary goal of this protocol is to improve our understanding of increased susceptibility to developing substance addiction. We focus here on particular gene x environment interactions as increased risk factors for substance dependence. The emphasis is on monoaminergic neurotransmitter-related genes thought to influence adaptability to the environment, and, therefore, on cognitive domains related to dopamine and serotonin: reward and punishment learning, and impulse control. To achieve the above objective, the study will be implemented by using cognitive, genetic and neuroimaging testing in adult addicted individuals along with matched controls.
Subject Population: We focus on adult (18-55 years old) smokers and matched non-smoking controls.
Experimental Design: This study involves cognitive, pharmacological and functional magnetic resonance imaging (fMRI) testing in a between-subject design involving neuroimaging and cognitive testing.
Outcome Measures: The primary outcome measures will be BOLD fMRI activation and behavioral performance on various cognitive tasks that deal with impulse control and reward learning, as a function of gene x environment interactions.
- Keywords
- fMRI, Monoamines, Environment, Genes, Reward Learning
- Medical subject headings
- Substance-Related Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measures will be BOLD fMRI activation and behavioral performance on various cognitive tasks that deal with impulse control and reward learning, as a function of gene x environment interactions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study start8 Jun 2012
- Study completion3 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Drug AddictionStudies 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
- Time perspective
- Retrospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Elliot Stein, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621607
- Sponsor's protocol ID
- 999912478
- Other IDs
- 12-DA-N478
- Status last verified
- 3 Oct 2017
- First submitted
- 14 Jun 2012
- Last updated
- 9 Dec 2019
- Results posted
- No
Publications
Barr CS, Newman TK, Lindell S, Shannon C, Champoux M, Lesch KP, Suomi SJ, Goldman D, Higley JD. Interaction between serotonin transporter gene variation and rearing condition in alcohol preference and consumption in female primates. Arch Gen Psychiatry. 2004 Nov;61(11):1146-52. doi: 10.1001/archpsyc.61.11.1146.
PubMed 15520362Belin D, Mar AC, Dalley JW, Robbins TW, Everitt BJ. High impulsivity predicts the switch to compulsive cocaine-taking. Science. 2008 Jun 6;320(5881):1352-5. doi: 10.1126/science.1158136.
PubMed 18535246Belsky J, Pluess M. Beyond diathesis stress: differential susceptibility to environmental influences. Psychol Bull. 2009 Nov;135(6):885-908. doi: 10.1037/a0017376.
PubMed 19883141
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene x Environment Interactions as Risk Factors for Addiction
- ClinicalTrials.gov ID
- NCT01621607
- Acronym / sponsor ID
- 999912478
- Keywords
- fMRI, Monoamines, Environment, Genes, Reward Learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 8 Jun 2012
- Study completion
- 3 Oct 2017
- First posted
- 18 Jun 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.
Background:
- The risk for becoming addicted to drugs varies among individual, even those using similar drugs in a similar way. It is not known why some people become addicted and others do not. Studies suggest that some genes may increase the risk of addiction. Negative life experiences may also affect the risk of addiction. Researchers want to test smokers and nonsmokers to study genetic and brain function traits that may lead to drug addiction.
Objectives:
- To understand brain function in people who may be at a higher risk of drug addiction.
Eligibility:
- Healthy volunteers between 18 and 55 years of age.
- Smokers (10 to 30 cigarettes per day for more than 2 years) and nonsmokers will be eligible.
Design:
- Participants will be screened with a physical exam and medical history. They will be tested for drug and alcohol use. A blood sample will be collected.
- The study will involve one visit. Participants will have a magnetic resonance imaging (MRI) scan.
- At the visit, participants will answer questions about their health and drug use habits. They will then be trained on the tasks they will do during the MRI scan. After the training, they will have the scan and perform the tasks. The scan and tasks will look at brain function related to rewards and impulsiveness.
- Other computer tests will be given after the scan. These tests will measure learning, memory, and impulsiveness.
Detailed description
Background: Even under similar drug use patterns, the risk for drug addiction varies from individual to individual. However, the neurobiological mechanisms underlying this variability are poorly understood and characterized. Studies suggest that certain traits observed in substance dependent individuals may actually precede drug use, and could augur future substance dependence. Understanding how the presence of these traits increases vulnerability to substance addiction could aid in the development of early intervention, preventative measures, as well as better treatment strategies.
Objective: The primary goal of this protocol is to improve our understanding of increased susceptibility to developing substance addiction. We focus here on particular gene x environment interactions as increased risk factors for substance dependence. The emphasis is on monoaminergic neurotransmitter-related genes thought to influence adaptability to the environment, and, therefore, on cognitive domains related to dopamine and serotonin: reward and punishment learning, and impulse control. To achieve the above objective, the study will be implemented by using cognitive, genetic and neuroimaging testing in adult addicted individuals along with matched controls.
Subject Population: We focus on adult (18-55 years old) smokers and matched non-smoking controls.
Experimental Design: This study involves cognitive, pharmacological and functional magnetic resonance imaging (fMRI) testing in a between-subject design involving neuroimaging and cognitive testing.
Outcome Measures: The primary outcome measures will be BOLD fMRI activation and behavioral performance on various cognitive tasks that deal with impulse control and reward learning, as a function of gene x environment interactions.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Between 18 and 55 years old (inclusive);
- Must be able to provide informed consent;
- Blood pressure (BP) and heart rate (HR) while sitting at or below the following values after five min rest: Systolic BP (SBP) 140 mm Hg, diastolic BP (DBP) 90 mm Hg, heart rate (HR) 100 bpm;
- No history of placement in special-education classes as a consequence of serious learning problems (to be assessed during the History and Physical assessment).
- Right-handed (based on Edinburgh Handedness Inventory);
Key exclusion criteria (7 listed)
- Report of a history of significant medical/neurological illness that might interfere with imaging data such as HIV positive status, cerebral vascular accident (CVA), central nervous system (CNS) tumor, traumatic brain injury, multiple sclerosis (MS) or other demyelinating diseases, epilepsy, or movement disorders;
- History of psychosis or any current DSM-IV axis I disorder (other than simple phobia);
- Current use of psychotropic medication that may alter attentional functioning (e.g., Clonidine, antipsychotics, Venlafaxine, stimulants);
- Current use of substances on the study visit that might influence performance on tasks as assessed by self-report, carbon monoxide (CO) monitoring, alcohol breathalyzer and urine testing; (and neuromotor evaluation, when needed). If participant is intoxicated at the time of the study visit; he/she will be rescheduled for a later visit.
- Meets criteria for abuse, or DSM-IV dependence, or dependence in partial remission, on any drug except nicotine. Past abuse of marijuana or alcohol is acceptable provided it is at least 1 year in the past.
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 will be BOLD fMRI activation and behavioral performance on various cognitive tasks that deal with impulse control and reward learning, as a function of gene x environment interactions.
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 9 Dec 2019.
- Background: PubMed 15520362Barr CS, Newman TK, Lindell S, Shannon C, Champoux M, Lesch KP, Suomi SJ, Goldman D, Higley JD. Interaction between serotonin transporter gene variation and rearing condition in alcohol preference and consumption in female primates. Arch Gen Psychiatry. 2004 Nov;61(11):1146-52. doi: 10.1001/archpsyc.61.11.1146.
- Background: PubMed 18535246Belin D, Mar AC, Dalley JW, Robbins TW, Everitt BJ. High impulsivity predicts the switch to compulsive cocaine-taking. Science. 2008 Jun 6;320(5881):1352-5. doi: 10.1126/science.1158136.
- Background: PubMed 19883141Belsky J, Pluess M. Beyond diathesis stress: differential susceptibility to environmental influences. Psychol Bull. 2009 Nov;135(6):885-908. doi: 10.1037/a0017376.
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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.
Elliot Stein, 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 Drug Addiction and Vulnerability to Substance Addiction, 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 11 inclusion and 7 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 9 Dec 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?
The primary outcome measures will be BOLD fMRI activation and behavioral performance on various cognitive tasks that deal with impulse control and reward learning, as a function of gene x environment interactions.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01621607, which also lists 3 linked publications.
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 9 Dec 2019.