NCT01036126

Brief Summary

Background: \- Relapse to drug abuse often happens in the presence of stimuli that are associated with previous drug use, also known as cues. Drug-taking behavior appears to be partly controlled by such cues. Some research suggests that cue-induced craving states are responsible for drug use and relapse, but other research suggests that cues can control drug taking without conscious craving or even awareness. Researchers are interested in using functional magnetic resonance imaging (fMRI) to study how individuals respond to drug-related cues and how these cues affect craving on a conscious or unconscious level. Objectives: \- To determine how drug-related stimuli (cues) affect thinking, information processing, and body reactions in current drug users. Eligibility: \- Individuals between 18 and 50 years of age who are dependent on either tobacco or crack-cocaine, or are healthy volunteers who are not dependent on either drug. Design:

  • The study will require two sessions, a training session and a testing session, that will take place within 48 hours of each other. Between the two test sessions, participants may not consume alcohol, tobacco, or illegal drugs, and must restrict caffeine consumption.
  • During the first session, participants will complete questionnaires about tobacco/cocaine use and craving, and will be trained on the tasks to be performed in the MRI scanner.
  • During the second session, participants will perform concentration tasks and look at pictures, some of which will be tobacco/cocaine related. Body reactions such as heart rate, pupil dilation, and sweating will be measured during this session. Some participants will have actual MRI scanning, while others will have mock MRI scanning.
  • After the MRI session, participants will complete questionnaires about craving and responses to the scan.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2003

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

August 12, 2003

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 21, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2010

Completed
Last Updated

July 2, 2017

Status Verified

August 19, 2010

First QC Date

December 18, 2009

Last Update Submit

June 30, 2017

Conditions

Keywords

NicotineCocaineN-BackCravingDependence

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Smokers:
  • Regular smoking of greater than or equal to 20 cigarettes other than ultra-low nicotine cigarettes per day for at least two years. Experienced withdrawal signs after not smoking for several hours. Score on the Fagerstrom Test for Nicotine Dependence greater than or equal to 3.
  • No intention to quit or reduce tobacco use, and no treatment for tobacco dependence currently or during the previous 3 months.
  • No history of abuse of or dependence to any other drug.
  • Age at least 18 and not older than 50 years.
  • Controls:
  • Smoked less than 5 cigarettes during lifetime
  • No history of abuse of or dependence to any drug, including alcohol.
  • Age at least 18 and not older than 50 years.
  • Cocaine abusers:
  • Reported regular crack-cocaine use for at least six months. Meeting DSM-IV criteria for cocaine dependence.
  • No intention to quit or reduce cocaine use, and no treatment for cocaine dependence currently or during the previous 3 months.
  • Age at least 18 and not older than 50 years.
  • Controls:
  • No history of dependence on any drug except nicotine.
  • +1 more criteria

You may not qualify if:

  • Female subjects: pregnancy (a urine pregnancy test will be performed before each MRI experimental session).
  • Presence of metal objects in the body (e.g. some artificial joints, bone pins, surgical clips, skull plate, dental braces) or implanted electronic devices (e.g. cardiac pacemaker, neurostimulator)
  • Claustrophobia.
  • For experiments involving MRI, left-handed or ambidextrous as determined by the Edinburgh Handedness Inventory.
  • Cardiovascular or cerebrovascular diseases.
  • Major psychiatric disorders including mood, anxiety or psychotic disorders.
  • History of or current neurological illnesses including seizure disorders, migraine, multiple sclerosis, movement disorders, head trauma, CVA or CNS tumor. Gross structural brain abnormalities as revealed by T1 weighted images. Use of medication that may affect the CNS at the time of scanning (e.g. b-blocker or analgesics).
  • Learning disability, amnesia or other conditions that impede memory and attention. IQ less than 85.
  • HIV-positivity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute on Drug Abuse, Biomedical Research Center (BRC)

Baltimore, Maryland, 21224, United States

Location

Related Publications (3)

  • Abrams DB, Monti PM, Carey KB, Pinto RP, Jacobus SI. Reactivity to smoking cues and relapse: two studies of discriminant validity. Behav Res Ther. 1988;26(3):225-33. doi: 10.1016/0005-7967(88)90003-4. No abstract available.

    PMID: 3408457BACKGROUND
  • Bagby RM, Parker JD, Taylor GJ. The twenty-item Toronto Alexithymia Scale--I. Item selection and cross-validation of the factor structure. J Psychosom Res. 1994 Jan;38(1):23-32. doi: 10.1016/0022-3999(94)90005-1.

    PMID: 8126686BACKGROUND
  • Baker TB, Morse E, Sherman JE. The motivation to use drugs: a psychobiological analysis of urges. Nebr Symp Motiv. 1986;34:257-323.

    PMID: 3627296BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

December 18, 2009

First Posted

December 21, 2009

Study Start

August 12, 2003

Study Completion

August 19, 2010

Last Updated

July 2, 2017

Record last verified: 2010-08-19

Locations