RECRUITING

Outcome Inference in the Sensory Preconditioning Task in Opioid-Use Disorder

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Background: People with addictions often find it hard to choose the long-term benefits of abstinence over the short-term effects of using drugs. Researchers think this is partly due to parts of the brain involved in certain types of learning and decision-making. Researchers want to test these basic functions using a simple task with pictures and odors. Objective: To see if performance in a learning task differs between people who have opioid-use disorder and people who don t. Eligibility: Adults 21-60 years old who are willing to fast for at least 6 hours and smell food odors. Those with an opioid-use disorder must either not use for at least 3 weeks or be in treatment. Design: Participants will have 1 visit that will take up to 5 hours. Before the visit, participants will be asked to not eat or drink anything except water for at least 6 hours. At the visit, participants will be checked for signs of intoxication. Participants will give urine and breath samples. Participants will have tests of learning and behavior. They will look at shapes on a computer screen. The shapes will be paired with different food odors. The odors will come from a sterile tube placed under the nose. Participants will have their breathing monitored with a belt around the upper abdomen. About 30 days and 60 days later, participants will be called and asked about their drug use over the past 30 days.

Official Title

Outcome Inference in the Sensory Preconditioning Task in Opioid-use Disorder

Quick Facts

Study Start:2019-06-07
Study Completion:2026-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03745339

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age between 21 and 65 years inclusive. Rationale: objective olfactory impairment grows more prevalent with age; after age 53, the prevalence is 24.5%, increasing to 62.5 % in people aged 80-97 years.
  2. * Willing to fast for at least 6 hours prior to the study session and be exposed to food odors. These will be assessed with the "019 Additional History Form" questionnaire.
  3. * History of opioid-use disorder (DSM-5), to be assessed via the Mini International Neuropsychiatric Interview (MINI) or the Structured Clinical Interview for DSM-5 (SCID). History of SUDs can include substances in addition to opioids (e.g., cocaine).
  4. * Abstinent \> 3 weeks from all illicit substances (tobacco smoking and nondependent drinking permissible), to be assessed via 30-day timeline follow-back calendar. (Current abstinence will be confirmed via urine screen: see exclusion criteria.) Rationale: Although heterogeneity will be considerable, what all enrollees will have in common is having become abstinent from opioids long enough to be past withdrawal symptoms. Their heterogeneity in duration of abstinence and other drug-history measures will enable us to examine relationships between those things and inferencing performance.
  1. * Anosmia, dysosmia, or hyposmia (poor olfactory function), to be assessed via Sniffin Sticks threshold test \<4 or via Sniffin Sticks odor identification test \<10.
  2. * History of any neurological condition resulting in inability to perform study task. Examples include but not limited to degenerative processes of the CNS (Parkinson disease, Alzheimer disease); other neurologic diseases (Huntington disease, multiple sclerosis, other motor-neuron diseases); inflammatory conditions (sarcoidosis, Wegener granulomatosis); or significant cerebrovascular disease including (but not limited to) epilepsy, stroke, or meningitis; traumatic brain injury (TBI) or major head trauma with sustained loss of consciousness (\>30 min). To be assessed by history and physical and evaluation to sign screening consent. Eligibility will be determined based on MAI review of participants ability to perform study task. MAI will consider but is not limited to H and P results for mental status exam, language exam, and attention span exam. Rationale: any of these could impair task performance.
  3. * History of current (past 12 months) uncontrolled DSM-5 major psychiatric disorder including major affective disorder, obsessive-compulsive disorder, schizophrenia, and PTSD. (Candidates will not be excluded for a history of major psychiatric disorder that is now being successfully treated.) To be assessed by MINI or SCID interview. Rationale: could impair task performance.
  4. * History of anaphylaxis due to, e.g., significant asthma, food or non-food allergy, or intolerance to odors (including latex, detergents, soaps, etc.). To be assessed by history and physical. Rationale: could make odorant exposure risky.
  5. * Current use of medications or substances that affect alertness and that cannot be withheld on the morning of the study visit (e.g., barbiturates, benzodiazepines, cannabinoids, chloral hydrate, haloperidol, lithium, carbamazepine, phenytoin, etc.). To be assessed by history and physical. Whether candidate will be requested to withhold any medication will be determined based on MAI judgment. Additionally, if participant has a BrAC \>0.08, MAI will use clinical judgement to determine if participant should be rescheduled. Rationale: could impair task performance.
  6. * For women: pregnancy. To be assessed by history and physical and by urine testing. Rationale: Could affect task performance-physiological and hormonal changes during pregnancy influence rhinological function.
  7. * Any other medical illness or condition that in the judgment of the investigators is incompatible with study participation.
  8. * History of a substance-use disorder (except nicotine, for matching purposes), or current use of any drug for nonmedical purposes. Controls, who cannot have a history of OUD, will be assessed by their medical history and physical examination for the presence of any signs or symptoms consistent with opioid withdrawal. Any Control with any sign or symptom consistent with opioid withdrawal will be evaluated by the MAI to rule out opioid withdrawal if possible.
  9. * Urine positive for any illicit drug. Rationale: Controls should have no drug use. A UDS that is positive for a prescribed medication that the MAI has determined is not due to illicit drug use will not be exclusionary.
  10. * Urine positive for any illicit drug. Rationale: Abstinent OUD group should have no drug use in the last 3 weeks which would include the several-day time frame to which urine screens are sensitive. A UDS that is positive for a prescribed medication that the MAI has determined is not due to illicit drug use will not be exclusionary.
  11. * Current signs or symptoms of opioid withdrawal. These will be assessed in the Abstinent group via the Clinical Opioid Withdrawal Scale (COWS) and the Subjective Opioid Withdrawal Scale (SOWS).

Contacts and Locations

Study Contact

NIDA IRP Screening Team
CONTACT
(800) 535-8254
researchstudies@nida.nih.gov
Thorsten Kahnt, Ph.D.
CONTACT
(667) 312-5175
thorsten.kahnt@nih.gov

Principal Investigator

Thorsten Kahnt, Ph.D.
PRINCIPAL_INVESTIGATOR
National Institute on Drug Abuse (NIDA)

Study Locations (Sites)

National Institute on Drug Abuse
Baltimore, Maryland, 21224
United States

Collaborators and Investigators

Sponsor: National Institute on Drug Abuse (NIDA)

  • Thorsten Kahnt, Ph.D., PRINCIPAL_INVESTIGATOR, National Institute on Drug Abuse (NIDA)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-06-07
Study Completion Date2026-10-01

Study Record Updates

Study Start Date2019-06-07
Study Completion Date2026-10-01

Terms related to this study

Keywords Provided by Researchers

  • Addiction
  • Orbitofrontal Cortex
  • Associative Learning
  • Implicit Learning
  • Natural History

Additional Relevant MeSH Terms

  • Opioid-Related Disorders
  • Drug Addiction