NCT01621607

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 8, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2012

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2017

Completed
Last Updated

December 9, 2019

Status Verified

October 3, 2017

First QC Date

June 14, 2012

Last Update Submit

December 6, 2019

Conditions

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;
  • 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.

Sponsors & Collaborators

Study Sites (1)

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

Location

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
  • 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

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

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

Study Completion

October 3, 2017

Last Updated

December 9, 2019

Record last verified: 2017-10-03

Locations