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

NCT03745339 | Recruiting

• 2 other identifiers: 99991901919-DA-N019
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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. ...

Conditions

Opioid-Related Disorders; Drug Addiction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Outcome inferencing in the probe test

  Percentage of trials with cues A and C in which the participant predicts any odor (sweet or savory), regardless of whether the prediction is correct.

  During task

Secondary Outcomes (5)

• Percentage of trials in which the odor prediction is correct.

  During task

• Response latency per cue type

  During task

• Amplitude of respiratory (sniff) responses per cue type

  During task

• Latency of respiratory (sniff) responses per cue type

  During task

• Drug use at follow-up

  30 and 60 days

Study Arms (3)

Abstinent OUD

Men and women with history of OUD, but abstinent for at least 3 weeks and not in agonist treatment

Controls

Men and women with no history of a substance-use disorder (except nicotine, for matching purposes) and not using any drug for nonmedical purposes

In-treatment OUD

Men and women with opioid use disorder (OUD) being treated with an agonist (buprenorphine or methadone)

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Community sample

You may qualify if:

• The enrollment target for the protocol is 120 (40 healthy controls, 40 patients on agonist maintenance, and 40 participants who have met DSM 5 criteria for OUD, but are now abstinent (for at least 3 weeks) and not on agonist maintenance.
• All Participants
• 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.
• 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.
• Additional Criteria for Abstinent OUD group
• 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).

You may not qualify if:

• Additional Criteria for In-treatment OUD group
• Current enrollment in treatment for OUD with buprenorphine or methadone (\>3 weeks on stable dose). Current use of illicit substances during treatment is permissible but not required. Rationale: Again, heterogeneity will be considerable, but what all enrollees will have in common is having sought treatment for their OUD and being currently maintained on an agonist that permits adaptive everyday functioning. Their heterogeneity in ongoing use of illicit substances will enable us to examine relationships between inferencing performance and treatment response.
• All participants
• Anosmia, dysosmia, or hyposmia (poor olfactory function), to be assessed via Sniffin Sticks threshold test \<4 or via Sniffin Sticks odor identification test \<10.
• 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.
• 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.
• 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.
• 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.
• 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.
• Any other medical illness or condition that in the judgment of the investigators is incompatible with study participation.
• Additional criteria for Control Group
• 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.
• Additional criteria for Abstinent Group
• 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).
• Additional criteria for In-treatment OUD group

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

RECRUITING

Related Publications (3)

• Schoenbaum G, Chang CY, Lucantonio F, Takahashi YK. Thinking Outside the Box: Orbitofrontal Cortex, Imagination, and How We Can Treat Addiction. Neuropsychopharmacology. 2016 Dec;41(13):2966-2976. doi: 10.1038/npp.2016.147. Epub 2016 Aug 11.

  PMID: 27510424 BACKGROUND

• Jones JL, Esber GR, McDannald MA, Gruber AJ, Hernandez A, Mirenzi A, Schoenbaum G. Orbitofrontal cortex supports behavior and learning using inferred but not cached values. Science. 2012 Nov 16;338(6109):953-6. doi: 10.1126/science.1227489.

  PMID: 23162000 BACKGROUND

• BROGDEN WJ. Sensory pre-conditioning of human subjects. J Exp Psychol. 1947 Dec;37(6):527-39. doi: 10.1037/h0058465. No abstract available.

  PMID: 18920626 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• Thorsten Kahnt, Ph.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NIDA IRP Screening Team

CONTACT

(800) 535-8254; researchstudies@nida.nih.gov

Thorsten Kahnt, Ph.D.

CONTACT

(667) 312-5175; thorsten.kahnt@nih.gov

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 19, 2018
• Study Start: June 7, 2019
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-02-13

Locations

US (1)