Outcome Inference in the Sensory Preconditioning Task in Opioid-Use Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-60
SponsorNational Institute on Drug Abuse (NIDA)
About this trial
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.
Eligibility criteria
Qualifiers
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.
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).
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
150 Participants
are grouped into 3 trial groupsSponsors and collaborators
Source ClinicalTrials.gov