NCT01621607

Completed

Individual Differences in Reward and Impulse Control

National Institute on Drug Abuse (NIDA)Source

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Other study identifiers

Sponsor study identifier

999912478

Secondary identifiers

12-DA-N478

Study Type

observational

Actual enrollment (reported)

89

Locations

1 country

Sites

1

Timeline

Study Start

June 8, 2012

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

October 3, 2017

Date type not reported

This date has not been verified as actual or estimated.

Brief 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. 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 89 participants
Study completion date: October 3, 2017
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 8, 2012
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
June 14, 2012
Actual (reported)
First Posted
June 18, 2012
Actual (reported)
Study Completion
October 3, 2017
Date type not reported
This date has not been verified as actual or estimated.

Last Updated: December 9, 2019
Status Verified: October 3, 2017
Last Update Submitted: December 6, 2019

Conditions

Drug Addiction Vulnerability to Substance Addiction

Keywords

fMRIMonoaminesEnvironmentGenesReward Learning

Outcome Measures

Primary Outcomes (1)

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.

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Between 18 and 55 years old (inclusive);
Must be able to provide informed consent;

Sponsors & Collaborators

National Institute on Drug Abuse (NIDA)
NIHlead

Study Sites (1)

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

Related Publications (3)

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.
PMID: 15520362BACKGROUND
Belin 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.
PMID: 18535246BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

Elliot Stein, Ph.D.
National Institute on Drug Abuse (NIDA)
PRINCIPAL INVESTIGATOR

Enrollment

89 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Time Perspective: RETROSPECTIVE
Sponsor Type: NIH
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 14, 2012

First Posted

June 18, 2012

Study Start

June 8, 2012

Date type not reported

This date has not been verified as actual or estimated.

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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).

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)

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Belsky J, Pluess M. Beyond diathesis stress: differential susceptibility to environmental influences. Psychol Bull. 2009 Nov;135(6):885-908. doi: 10.1037/a0017376.

PMID: 19883141BACKGROUND

Study Completion

October 3, 2017

Date type not reported

This date has not been verified as actual or estimated.

Last Updated

December 9, 2019

Record last verified: 2017-10-03

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT01621607
Data provider: ClinicalTrials.gov
Source updated: 2019-12-09
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:22 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations