NCT01036230

Brief Summary

Background:

  • Environmental cues frequently induce expectancies in individuals that may strongly influence the actual experience associated with the cue. This has both positive and negative consequences for behavior and decision making. For instance, when an addicted individual experiences cues associated with imminent drug taking, an expectancy of the coming experience is also formed and very likely has an effect on the subsequent experience of the drug.
  • Researchers are interested in studying how the brain responds to these kinds of environmental cues and expectancies in order to learn more about addiction and craving in substance-abusing individuals. Objectives:
  • To compare the response to rewards (both drug-related and non-drug-related) in cocaine users and non-using individuals.
  • To study the effect of expectation on reward-related (both drug-induced and non-drug-induced) responses and brain activity in cocaine users and non-using individuals. Eligibility:
  • Individuals between 18 and 45 years of age who are regular cocaine users but otherwise healthy, or healthy individuals who are not cocaine users. Design:
  • This study involves two experiments. Participants will be assigned to one or both experiments.
  • Participants must not use any drugs for at least 3 days before the visit, may not consume alcohol for 24 hours before the visit, and may not consume caffeinated beverages for 12 hours before the visit. On the day of the visit, participants will provide both urine and breath samples to test for drug/alcohol use.
  • Experiment 1: In the MRI scanner, participants will respond to questions and images on a screen, and will receive small amounts of flavored liquid (chocolate or cherry) through a tube in the mouth.
  • Experiment 2: In the MRI scanner, participants will respond to questions and images on a screen, and will receive injections of liquid (saline solution or a drug that provides a high similar to cocaine) through an intravenous line. Participants in this experiment will return for follow-up visits and provide urine samples for further study.
  • The specific assignment (to Experiment 1 or Experiment 2 or both experiments) will determine the number of study days and follow-up visits required.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2010

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

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
5 months until next milestone

Study Start

First participant enrolled

May 24, 2010

Completed
8.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2019

Completed
Last Updated

April 5, 2019

Status Verified

February 25, 2019

First QC Date

December 18, 2009

Last Update Submit

April 3, 2019

Conditions

Keywords

fMRIMethylphenidateTasteOlfactionAddiction

Outcome Measures

Primary Outcomes (1)

  • To compare the response to rewards (drug and non-drug related) in cocaine dependent and non- dependent individuals and study the effect of expectation on reward-related (both drug and non-drug induced) subjective responses and neuronal activity.

Secondary Outcomes (1)

  • To compare visual and olfactory cues as they relate to receipt of a non-drug reward. Olfactory cues follow a more direct path into the limbic system and thus, may alter reward system functioning differently than do visual cues.

Eligibility Criteria

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

You may qualify if:

  • ALL PARTICIPANTS MUST:
  • Be between the ages of 18-50.
  • Be in good health.
  • Be right-handed.
  • Like the flavors of cherry Kool-Aid and Hershey's chocolate sauce.
  • COCAIN DEPENDENT PARTICIPANTS MUST:
  • Demonstrate that they area cocaine dependent.
  • Be users of crack cocaine, free base cocaine or intravenous cocaine.
  • Fe free of dependence on other substances except nicotine.
  • Be free of abuse of other substances besides marijuana or alcohol.
  • CONTROL PARTICIPANTS MUST:
  • Be free of current or past DSM-IVTR substance use disorder except nicotine dependence or past substance abuse diagnosed iwth the single criterion of recurrent substance use in situations in which it is physically hazardous.

You may not qualify if:

  • Participants will be excluded if they:
  • Are not suitable to undergo an fMRI experiment due to pregnancy, implanted metallic devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts), body morphology or claustrophobia.
  • Have cardiovascular disease, including but not limited to clinically significant arrhythmia, coronary artery disease and hypertension.
  • Have coagulopathies, history of or current superficial or deep vein thrombosis, musculoskeletal abnormalities restricting an individual's ability to lie flat for extended periods of time.
  • Have HIV or syphilis.
  • Have any neurological illnesses to include, but not limited to, seizure disorders, frequent migraine, multiple sclerosis, movement disorders, or history of head traume, CVA, CNS tumor
  • Have an abnormality on screening MRI scans that would place the participant at increased risk from blood pressure elevations related to protocol procedures (methylphenidate injections) or would impair the quality of data gathered on the participant.
  • Have other major medical illnesses likely to interfere with study results or safety of an individual during participation.
  • Have any current major psychiatric disorders to include, but not limited to, mood, anxiety, psychotic disorders, or substance-induced disorders.
  • Regularly use any prescription, over-the-counter or herbal medication that may alter CNS function, cardiovascular function or neuronal-vascular coupling.
  • Are actively seeking or engaged in substance abuse treatment.
  • Are lactating.
  • Are cognitively impaired or learning disabled.

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)

  • Marlatt GA. Cue exposure and relapse prevention in the treatment of addictive behaviors. Addict Behav. 1990;15(4):395-9. doi: 10.1016/0306-4603(90)90048-3.

    PMID: 2248112BACKGROUND
  • Childress AR, Hole AV, Ehrman RN, Robbins SJ, McLellan AT, O'Brien CP. Cue reactivity and cue reactivity interventions in drug dependence. NIDA Res Monogr. 1993;137:73-95.

    PMID: 8289929BACKGROUND
  • Ito R, Dalley JW, Robbins TW, Everitt BJ. Dopamine release in the dorsal striatum during cocaine-seeking behavior under the control of a drug-associated cue. J Neurosci. 2002 Jul 15;22(14):6247-53. doi: 10.1523/JNEUROSCI.22-14-06247.2002.

    PMID: 12122083BACKGROUND

MeSH Terms

Conditions

Substance-Related DisordersAnosmiaBehavior, Addictive

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersOlfaction DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Betty Jo Salmeron, M.D.

    National Institute on Drug Abuse (NIDA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
OTHER
Sponsor Type
NIH

Study Record Dates

First Submitted

December 18, 2009

First Posted

December 21, 2009

Study Start

May 24, 2010

Study Completion

February 25, 2019

Last Updated

April 5, 2019

Record last verified: 2019-02-25

Locations