AdolescentsNCT01443949
Teenagers, Drug Addiction, and Reward and Impulse Control
An observational study of Adolescents and Conduct Disorder, run by National Institute on Drug Abuse (NIDA).
Trial summary
Background: The risk for becoming addicted to drugs varies from person to person, even among those who use similar drugs in a similar way. Studies suggest that certain personality traits seen in people with drug addiction may be present before drug use. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Adolescents, Conduct Disorder, Vulnerability to Substance Addicition
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 11 Sep 2011to 4 Apr 2013
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All participants:
- Between 13 and 17 years old (inclusive);
- Must be able to provide informed assent and have a parent/guardian who can 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;
- 12-lead standard ECG and three-minute rhythm strip without clinically relevant abnormalities;
- Estimated IQ (Bullet) 85 determined by the Wechsler Abbreviated Scale of Intelligence (The Psychological Corporation, 1999);
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- Right-handed (based on Edinburgh Handedness Inventory).
- Eligible to enter the MRI scanner, as determined though self and parent (guardian) report on the MRI screening form (from the screening protocol 06-DA-N415).
- Group EE:
- History of substance use on 5 or more occasions (not including over-the-counter medications and energy drinks) as assessed through the Substance Use Questionnaire.
- Group CD-NE:
- History of diagnosis with conduct disorder, assessed from parental or self-report (and verified by study-clinician).
- Group CD-EE:
- History of diagnosis with conduct disorder, assessed from parental or self-report (and verified by study-clinician);
- History of substance use on 5 or more occasions (not including over-the-counter medications and energy drinks) as assessed through the Substance Use Questionnaire.
Who cannot join
- All participants:
- 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 and conduct disorder);
- Current use of psychotropic medication that may alter attentional functioning (e.g., Clonidine, antipsychotics, Venlafaxine, stimulants);
- Current use of substances (not including over-the-counter medications and energy drinks) as assessed by self-report, carbon monoxide (CO) monitoring, alcohol breathalyzer and urine testing;
- Pregnancy, which will be assessed by history during screening and by urine testing on scan days;
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- Claustrophobia by self and/or parent (guardian) report, or through response to the mock-scanner environment, severe enough to preclude toleration of the scanning environment.
- Group NE:
- History of substance use on 5 or more occasions (not including over-the-counter medications and energy drinks) as assessed through the Substance Use Questionnaire;
- History of diagnosis with conduct disorder, assessed from parental or self-report (and verified by study-clinician).
- Group EE:
- History of diagnosis with conduct disorder, assessed from parental report (and verified by study-clinician).
- Group CD-NE:
- History of substance use on 5 or more occasions (not including over-the-counter medications and energy drinks) as assessed through the Substance Use Questionnaire.
About this study
Official title: Individual Differences in Reward and Impulse Control Circuitry as Risk Factors for Addiction
Background:
- The risk for becoming addicted to drugs varies from person to person, even among those who use similar drugs in a similar way. Studies suggest that certain personality traits seen in people with drug addiction may be present before drug use. These traits include responding differently to rewards or impulsivity. Early use of drugs (before age 15) is also associated strongly with drug addiction later in life. Researchers want to study teenagers with and without certain behavioral problems, including those who have used drugs and those who have not. This may help them better understand behaviors that might predict future drug addiction.
Read more
Objectives:
- To understand brain function in teenagers who may be at a higher risk than others to drug addiction.
Eligibility:
- Teenagers between 13 and 17 years of age who fit into one of four groups:
- Have never or rarely used drugs
- Have never or rarely used drugs and have conduct or behavior disorders
- Have used drugs on many occasions
- Have used drugs on many occasions and have conduct or behavior disorders
Design:
- Participants will be screened with a medical history, and physical and neurological exams. They will also have blood and urine tests. Participants will answer questions about past drug use and any current medications. They will also have a breathalyzer and carbon monoxide breath test to check for recent drug and alcohol use.
- This study requires four visits to the clinical center for magnetic resonance imaging (MRI) scans and other tests.
- The first study visit will include training for the MRI scans. Participants will practice the tasks in front of a computer and in a mock (fake) MRI machine. Participants will also be asked several questions about their personality and past experiences.
- Researchers will test changes to tryptophan and dopamine levels. Both of these chemicals affect decision making and brain function. On the three study visits, participants will have the following tests in a randomly selected order. One study will be done at each visit.
- MRI scans with changes to dopamine and tryptophan levels
- MRI scans with changes to dopamine only (with placebo)
- MRI scans with changes to tryptophan only (with placebo)
- Participants will be monitored with frequent blood draws and other tests during the study visits....
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 reward and punishment learning, and impulse control, with an emphasis on the underlying role of dopamine and serotonin function in these two cognitive functions. Further, given that cortical plasticity is enhanced during childhood and adolescence, we begin to address whether early exposure to substances enhances neurobiological changes that make an individual vulnerable to subsequent substance addiction.
Subject Population: We focus on adolescents (13-17 years old) with known increased vulnerability to substance addiction individuals with early exposure to substances, i.e. , those who have used drugs on multiple occasions before the age of 15, and those diagnosed with conduct disorder and who are not as yet substance dependent, along with matched controls.
Experimental Design: This study involves cognitive, pharmacological and functional magnetic resonance imaging (fMRI) testing in a mixed, within/between-subject design. Based upon power analyses, we estimate needing 30 participants in each of 4 groups early exposure (EE), conduct disorder (CD-NE), conduct disorder with early exposure (CD-EE), and controls with no early exposure (NE) to complete the experiment. This is a within subjects, placebo controlled, crossover design with participants tested before and after 1) cabergoline (D2 receptor agonist) treatment, 2) acute tryptophan depletion, and 3) placebo.
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 before and after each of the three treatments listed above. Secondary outcome measures include gene x environment interactions and stress and novelty-seeking measures.
- Keywords
- fMRI, Reward, Adolescents, Impulse Control, Cabergoline
- Medical subject headings
- Conduct Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Bold fMRI activation and behavioral performance on various cognitive tasks that deal with impulse control and reward learning before and after each of the three treatments.
Secondary outcomes (1)
Secondary outcome measures include gene x environment interactions and stress and novelty-seeking measures.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study start11 Sep 2011
- Study completion4 Apr 2013
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 AdolescentsStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Elliot Stein, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443949
- Sponsor's protocol ID
- 999911466
- Other IDs
- 11-DA-N466
- Status last verified
- 4 Apr 2013
- First submitted
- 29 Sep 2011
- Last updated
- 12 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, Jonassaint C, Pluess M, Stanton M, Brummett B, Williams R. Vulnerability genes or plasticity genes? Mol Psychiatry. 2009 Aug;14(8):746-54. doi: 10.1038/mp.2009.44. Epub 2009 May 19.
PubMed 19455150
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Differences in Reward and Impulse Control Circuitry as Risk Factors for Addiction
- ClinicalTrials.gov ID
- NCT01443949
- Acronym / sponsor ID
- 999911466
- Keywords
- fMRI, Reward, Adolescents, Impulse Control, Cabergoline
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 11 Sep 2011
- Study completion
- 4 Apr 2013
- First posted
- 30 Sep 2011 (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 from person to person, even among those who use similar drugs in a similar way. Studies suggest that certain personality traits seen in people with drug addiction may be present before drug use. These traits include responding differently to rewards or impulsivity. Early use of drugs (before age 15) is also associated strongly with drug addiction later in life. Researchers want to study teenagers with and without certain behavioral problems, including those who have used drugs and those who have not. This may help them better understand behaviors that might predict future drug addiction.
Objectives:
- To understand brain function in teenagers who may be at a higher risk than others to drug addiction.
Eligibility:
- Teenagers between 13 and 17 years of age who fit into one of four groups:
- Have never or rarely used drugs
- Have never or rarely used drugs and have conduct or behavior disorders
- Have used drugs on many occasions
- Have used drugs on many occasions and have conduct or behavior disorders
Design:
- Participants will be screened with a medical history, and physical and neurological exams. They will also have blood and urine tests. Participants will answer questions about past drug use and any current medications. They will also have a breathalyzer and carbon monoxide breath test to check for recent drug and alcohol use.
- This study requires four visits to the clinical center for magnetic resonance imaging (MRI) scans and other tests.
- The first study visit will include training for the MRI scans. Participants will practice the tasks in front of a computer and in a mock (fake) MRI machine. Participants will also be asked several questions about their personality and past experiences.
- Researchers will test changes to tryptophan and dopamine levels. Both of these chemicals affect decision making and brain function. On the three study visits, participants will have the following tests in a randomly selected order. One study will be done at each visit.
- MRI scans with changes to dopamine and tryptophan levels
- MRI scans with changes to dopamine only (with placebo)
- MRI scans with changes to tryptophan only (with placebo)
- Participants will be monitored with frequent blood draws and other tests during the study visits....
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 reward and punishment learning, and impulse control, with an emphasis on the underlying role of dopamine and serotonin function in these two cognitive functions. Further, given that cortical plasticity is enhanced during childhood and adolescence, we begin to address whether early exposure to substances enhances neurobiological changes that make an individual vulnerable to subsequent substance addiction.
Subject Population: We focus on adolescents (13-17 years old) with known increased vulnerability to substance addiction individuals with early exposure to substances, i.e. , those who have used drugs on multiple occasions before the age of 15, and those diagnosed with conduct disorder and who are not as yet substance dependent, along with matched controls.
Experimental Design: This study involves cognitive, pharmacological and functional magnetic resonance imaging (fMRI) testing in a mixed, within/between-subject design. Based upon power analyses, we estimate needing 30 participants in each of 4 groups early exposure (EE), conduct disorder (CD-NE), conduct disorder with early exposure (CD-EE), and controls with no early exposure (NE) to complete the experiment. This is a within subjects, placebo controlled, crossover design with participants tested before and after 1) cabergoline (D2 receptor agonist) treatment, 2) acute tryptophan depletion, and 3) placebo.
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 before and after each of the three treatments listed above. Secondary outcome measures include gene x environment interactions and stress and novelty-seeking measures.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- Between 13 and 17 years old (inclusive);
- Must be able to provide informed assent and have a parent/guardian who can 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;
- 12-lead standard ECG and three-minute rhythm strip without clinically relevant abnormalities;
- Estimated IQ (Bullet) 85 determined by the Wechsler Abbreviated Scale of Intelligence (The Psychological Corporation, 1999);
Key exclusion criteria (14 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 and conduct disorder);
- Current use of psychotropic medication that may alter attentional functioning (e.g., Clonidine, antipsychotics, Venlafaxine, stimulants);
- Current use of substances (not including over-the-counter medications and energy drinks) as assessed by self-report, carbon monoxide (CO) monitoring, alcohol breathalyzer and urine testing;
- Pregnancy, which will be assessed by history during screening and by urine testing on scan days;
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
Bold fMRI activation and behavioral performance on various cognitive tasks that deal with impulse control and reward learning before and after each of the three treatments.
1 secondary outcome
Secondary outcome measures include gene x environment interactions and stress and novelty-seeking measures.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 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 19455150Belsky J, Jonassaint C, Pluess M, Stanton M, Brummett B, Williams R. Vulnerability genes or plasticity genes? Mol Psychiatry. 2009 Aug;14(8):746-54. doi: 10.1038/mp.2009.44. Epub 2009 May 19.
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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)
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescents and Conduct Disorder, run by National Institute on Drug Abuse (NIDA).
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 15 inclusion and 14 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: withdrawn, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Bold fMRI activation and behavioral performance on various cognitive tasks that deal with impulse control and reward learning before and after each of the three treatments.. 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 NCT01443949, 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 12 Dec 2019.