Opioid-Related Disorders Clinical Trial
Official title:
Biobehavioral Study of Opioid Drug Seeking Behavior: Study 4
The purpose is to study the extent to which stress and other factors, including money, the
amount of drug available and the amount of work effort, affect drug choice.
This study will assess whether exposure to yohimbine, a drug stressor, increases opioid
craving- and -seeking behavior. We will determine whether these behavioral outcomes are
associated with biobehavioral stress markers: increased saliva cortisol levels,
cardiovascular response (heart rate and blood pressure), and negative mood state.
Physical, environmental, and pharmacological stressors have been repeatedly shown to
increase self-administration of various abused substances in both preclinical and human
studies. The primary aim of the proposed work is to assess the effects of yohimbine, a
pharmacological agent, used to create an objectively-measured stress response, upon
opioid-seeking behavior and craving.
Participants will first be an outpatient and must come to the Jefferson Avenue Research
Program daily to receive buprenorphine doses. This phase will last at least 10 days or
longer. Three times per week during the first two weeks (i.e., on 6 different days),
participants will be asked to provide urine samples and to complete questionnaires that ask
about opiate withdrawal symptoms.
Next, participants will live on an inpatient research unit for at least 11 consecutive
nights and possibly up to 15 consecutive nights. During this stay they will participate in a
total of eight experimental sessions. Participants will take part in multiple trials in
which they have the opportunity to choose drug, hydromorphone (HYD), or money. HYD is a drug
that is currently used as a cough suppressant and to relieve pain. During the first two test
sessions, participants will receive a sample of the drug doses that can be chosen. Before
each of the final 6 test sessions begin, participants will be given a capsule containing
either different doses of the drug yohimbine or a placebo (blank). Yohimbine is a drug that
has been shown to produce a "stress"-like response in humans. Then participants will have 12
opportunities to choose either drug or money by using a computer to earn choices.
Respiration rate, oxygen saturation, heart rate, and blood pressure will be monitored
throughout choice trials. Self-report questionnaires will be completed at different times
during the study.
After participants have completed the experimental procedures, they will again come to the
Jefferson Ave. Research Program daily to receive buprenorphine doses. The dose of
buprenorphine will be gradually decreased so that they will eventually be free from
medication. This will take three weeks. We will administer questionnaires and collect urine
samples three times each week to assess using illicit drugs.
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Observational Model: Case-Only, Time Perspective: Prospective
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