AzTrials
AzTrials

Drug DependenceNCT01036126

Automatic Versus Evaluative Components of Cue Reactivity

An observational study of Drug Dependence, 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
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Drug Dependence
How many people
320 participants
Where
1 siteUnited States
Study dates
12 Aug 2003to 19 Aug 2010
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
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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:
Show all 17Show fewer
  • 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.
  • No dependence on any other drug except nicotine. Recreational use of other drugs of abuse without meeting dependence criteria is not an exclusion criterion.
  • Age at least 18 and not older than 50 years.
  • Controls:
  • No history of dependence on any drug except nicotine.
  • Age at least 18 and not older than 50 years.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

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:

  • 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.
Read more

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.
Read the detailed description

Relapse to drug abuse often happens in the presence of stimuli that are associated with previous drug-use, and drug-taking behavior appears to be partly controlled by such cues. While some theories postulate that such facilitation is mediated by cue-induced craving states, others hypothesize that the underlying processes are highly automatized and can happen without conscious control or even awareness. One way to approach psychological mechanisms of cue reactivity is to measure disruption of ongoing mental activity by drug-related material in dependent individuals while manipulating the degree to which cognitive evaluative processes can unfold. Craving measurement under these conditions can elucidate its relationship with automatic processing versus conscious evaluation of drug cues. Autonomic and neural correlates can be identified by concomitant psychophysiological and fMRI recording. Results from these studies will shed light on the role of spontaneous automatic reactions versus cognitive evaluation for different measures of cue reactivity. By helping to elucidate the psychological mechanisms and neurobiological basis of drug-cue reactivity in dependent individuals, this may have substantial implications for the understanding of mechanisms and treatment of drug dependence. Thus, while there are no direct benefits to subjects participating in these experiments, the results may benefit the health of society. MRI-related risks to subjects (injury from metal implants, claustrophobia, temporary deafness due to the loud banging noises) will be minimized by prescreening and providing earplugs. Drug-related cues may induce acute craving; subjects will be dismissed only after craving levels have returned to baseline.

Conditions
Drug Dependence
Keywords
Nicotine, Cocaine, N-Back, Craving, Dependence
Medical subject headings
Substance-Related Disorders

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 start12 Aug 2003
  3. Study completion19 Aug 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01036126
Sponsor's protocol ID
999903384
Other IDs
03-DA-N384
Status last verified
19 Aug 2010
First submitted
18 Dec 2009
Last updated
2 Jul 2017
Results posted
No

Publications

  • 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.

    PubMed 3408457

  • 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.

    PubMed 8126686

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

    PubMed 3627296

Questions about this trial

What is this clinical trial studying?

An observational study of Drug Dependence, 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 17 inclusion and 9 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 2 Jul 2017. 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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01036126, 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 2 Jul 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in