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Drug AbuseNCT01036230

The Effects of Expectation on Natural and Drug -Induced Rewards

An observational study of Drug Abuse, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Drug Abuse
How many people
48 participants
Where
1 siteUnited States
Study dates
24 May 2010to 25 Feb 2019
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 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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:
Show all 12Show fewer
  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Baltimore, Maryland, 21224

Other trials in United States

About this study

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.
Read more

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.
Read the detailed description

Objective: Environmental cues frequently induce expectancies in the course of normal daily life. When an individual smells and sees the coffee before tasting it, an expectancy of the coming experience is formed that influences the actual experience of consuming the coffee. Similarly, when an addicted individual experiences cues associated with imminent drug taking, an expectancy of the coming experience is also formed. This protocol will examine neural responses to cues predictive of a stimulus (neutral or rewarding) and to the subsequent receipt of the predicted stimulus.

Study Population: Study participants will include 18-50 year old, male and non-pregnant female otherwise healthy cocaine dependent individuals and control individuals who have a history of some stimulant use but no history of abuse or dependence on any other drug other than nicotine.

Design: The study will employ fMRI to elucidate the neural underpinnings of reward processing. The rewarding stimuli to be studied will be taste stimuli (small squirt of juice or chocolate) and a drug stimulus (intravenous methylphenidate (IV MPH)). For taste stimuli, cues will vary in sensory modality (visual vs. olfactory) and in novelty (well-known vs. novel). Novel and well-known cue stimuli will be included on each experimental day so the development of expectancy can be studied as the cue-taste pairing is learned and compared to the well-known cue-taste pairing. The MPH/saline injections will receive a written cue.

Outcome Measures: BOLD fMRI signal to reward stimuli will be compared in the various cuing conditions.

Conditions
Drug Abuse
Keywords
fMRI, Methylphenidate, Taste, Olfaction, Addiction
Medical subject headings
Substance-Related Disorders, Anosmia, Behavior, Addictive

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

  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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2009 (estimated)
  2. Study start24 May 2010
  3. Study completion25 Feb 2019

Resources

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
Other
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01036230
Sponsor's protocol ID
999904397
Other IDs
04-DA-N397
Status last verified
25 Feb 2019
First submitted
18 Dec 2009
Last updated
5 Apr 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 2248112

  • 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.

    PubMed 8289929

  • 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.

    PubMed 12122083

Questions about this trial

What is this clinical trial studying?

An observational study of Drug Abuse, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.

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 12 inclusion and 13 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: finished, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

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.. 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 NCT01036230, 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 5 Apr 2019.

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