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

  • STATUS
    Recruiting
  • End date
    Oct 1, 2024
  • participants needed
    150
  • sponsor
    National Institute on Drug Abuse (NIDA)
Updated on 10 August 2022
opioid
drug use
buprenorphine
addiction
methadone
withdrawal symptom
toxicology screen
urine screening
Accepts healthy volunteers

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.

Description

Background. People with substance-use disorders may have difficulty guiding their behavior on the basis of not-yet-experienced outcomes such as long-term effects of substance use. Use of mental inferences about future outcomes can be tested in a relatively simple laboratory task called sensory preconditioning.

Objective. To test whether sensory-preconditioning performance is worse in people with opioid use disorder (OUD) than in healthy, demographically matched controls. To increase generalizability, we will examine OUD participants who are in agonist treatment (abstinent or not) and OUD participants who are abstinent but not in treatment. We do not have a hypothesis about differences between those two groups, but we hypothesize that among agonist-treated OUD participants, performance will correlate with degree of abstinence.

Participant population. We will enroll 3 groups of men and women: (1) history of OUD, but abstinent for at least 3 weeks and not in agonist treatment, (2) OUD being treated with an agonist (buprenorphine or methadone), (3) no history of a substance-use disorder (except nicotine, for matching purposes) and not using any drug for nonmedical purposes.

Experimental design. Between-groups cross-sectional single-session laboratory study, with telephone follow-up at 30 and 60 days.

Methods. Each participant will participate in a sensory preconditioning task conducted in a single session. The task uses food odors delivered via nasal cannula and paired with visual cues on a computer screen. There are three phases: (1) Preconditioning, in which 2 pairs of visual cues (A+B, C+D) are shown on the computer screen; participants should acquire automatic associations between A+B and between C+D. (2) Conditioning, in which participants learn associations between the second cue of each pair (B and D) and either a sweet odor (B1), a savory odor (B2), or no odor (D); and (3) Probe Test, in which participants predict whether a visual cue will be paired with the sweet odor, the savory odor, or no odor, by pressing a left, middle, or right button. No odors are actually delivered in the probe test. The test of inference-guided behavior is the ability to associate visual cues A and C with an odor despite their never having been directly paired with an odor. In telephone follow-up at 30 and 60 days, participants will be asked to report drug use and associated problems since the session or follow-up call.

Primary outcome measures. (1) Value-based outcome inference as measured using responding to cues A minus C in the probe test. It is defined as the percentage of trials in which behavioral responses indicate a prediction of any odorant (sweet or savory), independent of whether this prediction is correct. Responding to cues B minus D will be used as a covariate to control for differences in olfactory acuity and non-inference-based task performance.

Secondary outcome measures. (1) The percentage of trials in which the odor prediction is correct. (2) Response latency per cue type. (3) Amplitude and (4) latency of respiratory (sniff) responses per cue type. (5) Acquisition (% responding to B minus D in the last run of conditioning) during the training portion of the inferencing task. (6) Drug use and associated problems at follow-up.

Details
Condition Opioid-Related Disorders, Drug Addiction
Clinical Study IdentifierNCT03745339
SponsorNational Institute on Drug Abuse (NIDA)
Last Modified on10 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Control Group
Age between 21 and 60 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
Abstinent OUD group
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
Age between 21 and 60 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
History of opioid-use disorder (DSM-5), to be assessed via the Mini International
food odors. These will be assessed with the '019 Additional History Form'
Neuropsychiatric Interview (MINI). History of SUDs can include substances in
questionnaire
addition to opioids (e.g., cocaine)
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
drughistory measures will enable us to examine relationships between those things
and inferencing performance
In-treatment OUD group
Age between 21 and 60 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
Current enrollment in treatment for OUD with buprenorphine or methadone. Current
use of illicit substances during treatment is permissible but not required
food odors. These will be assessed with the '019 Additional History Form'
Rationale: Again, heterogeneity will be considerable, but what all enrollees will
questionnaire
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

Exclusion Criteria

Control Group only
Control Group and Abstinent Group
Anosmia, dysosmia, or hyposmia (poor olfactory function), to be assessed via Sniffin
- History of a substance-use disorder (except nicotine, for matching purposes), or
current use of any drug for nonmedical purposes
Anosmia, dysosmia, or hyposmia (poor olfactory function), to be assessed via
Sniffin
Sticks threshold test <4; or presence of a known smell, taste or ear-nose-throat disorder
to be assessed by history and physical
History of 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. To be assessed by history and physical. Rationale: any of these could
impair task performance
History of traumatic brain injury (TBI) or major head trauma with sustained loss of
consciousness (>30 min). To be assessed by history and physical. Rationale: could
impair task performance
History of neurosurgery, ear/nose/throat (ENT) surgery (including laryngectomies
tracheotomies), or cardiac surgery (including pacemaker or neurostimulator placement)
To be assessed by history and physical. Rationale: could impair task performance
Current use of medications that may impact olfaction including macrolides
antimycotics, fluoroquinolones, ACE inhibitors, protein kinase inhibitors, proton pump
inhibitors, and intranasal zinc products. To be assessed by history and physical
Rationale: could impair task performance
History of endocrine disorders, including hypothyroidism, hypoadrenalism, and diabetes
mellitus; significant medical illness including cardiovascular disease, cancer
chronic obstructive pulmonary disease, asthma, renal insufficiency requiring dialysis
etc. To be assessed by history and physical. Rationale: could impair task performance
History of DSM-5 major psychiatric disorder including uncontrolled major affective
disorder, obsessive-compulsive disorder, schizophrenia, and PTSD. (Candidates will not
be excluded for a history of depression that is now being successfully treated.) To be
assessed by MINI interview. Rationale: could impair task performance
History of significant food or non-food allergy, including latex, detergents, soaps
To be assessed by history and physical. Rationale: could make odorant exposure risky
Current sinusitis or allergic, acute, or toxic rhinitis or current nasal polyps or
tumors. To be assessed by history and physical. Rationale: could impair task
performance
Current use of medications that affect alertness (e.g. barbiturates, benzodiazepines
cannabinoids, chloral hydrate, haloperidol, lithium, carbamazepine, phenytoin, etc.)To
be assessed by history and physical. 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
Cognitive impairment severe enough to preclude informed consent or valid self-report
(per History & Physical and Evaluation to Sign Consent)
Urine positive for any illicit drug. Rationale: Controls should have no drug use
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. In-treatment OUD
participants may test positive during screening because they may have ongoing use
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). 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
In-treatment OUD group
Sticks threshold test <4; or presence of a known smell, taste or ear-nose-throat
disorder, to be assessed by history and physical
History of 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. To be assessed by history and physical. Rationale: any of these could
impair task performance
History of traumatic brain injury (TBI) or major head trauma with sustained loss of
consciousness (>30 min). To be assessed by history and physical. Rationale: could
impair task performance
History of neurosurgery, ear/nose/throat (ENT) surgery (including laryngectomies
tracheotomies), or cardiac surgery (including pacemaker or neurostimulator placement)
To be assessed by history and physical. Rationale: could impair task performance
Current use of medications that may impact olfaction including macrolides
antimycotics, fluoroquinolones, ACE inhibitors, protein kinase inhibitors, proton pump
inhibitors, and intranasal zinc products. To be assessed by history and physical
Rationale: could impair task performance
History of endocrine disorders, including hypothyroidism, hypoadrenalism, and diabetes
mellitus; significant medical illness including cardiovascular disease, cancer
chronic obstructive pulmonary disease, asthma, renal insufficiency requiring dialysis
etc. To be assessed by history and physical. Rationale: could impair task performance
History of DSM-5 major psychiatric disorder including uncontrolled major affective
disorder, obsessive-compulsive disorder, schizophrenia, and PTSD. (Candidates will not
be excluded for a history of depression that is now being successfully treated.) To be
assessed by MINI interview. Rationale: could impair task performance
History of significant food or non-food allergy, including latex, detergents, soaps
To be assessed by history and physical. Rationale: could make odorant exposure risky
Current sinusitis or allergic, acute, or toxic rhinitis or current nasal polyps or
tumors. To be assessed by history and physical. Rationale: could impair task
performance
Current use of medications that affect alertness (e.g. barbiturates, benzodiazepines
cannabinoids, chloral hydrate, haloperidol, lithium, carbamazepine, phenytoin, etc.)
To be assessed by history and physical. 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
Cognitive impairment severe enough to preclude informed consent or valid self-report
(per History & Physical and Evaluation to Sign Consent)
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