Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT02052258
Eligibility Criteria:
Inclusion Criteria:
* adult men 18 years or older
* meet DSM-IV criteria for opiate dependence, and no other active substance dependence disorder save nicotine dependence
* clinically stable, and low risk for suicide as determined by principal investigator and screening questionnaire
* abstinent from non-prescribed opiate use for at least two weeks from Baseline 1 and free from opiate withdrawal symptoms. If on agonist therapy, dose must be stable for 2 weeks before study visit.
* must be able to use nasal spray
* negative salivary drug screen, save for opiates
Exclusion Criteria:
* any active medical condition that in the opinion of the investigator will interfere with the objectives of the study
* any active, severe mental illness, neurological disorder, including schizophrenia, autism, Asperger's syndrome
* are unsuitable in any way to participate in this study, in the opinion of the investigator
* hospitalizations due to complications of an Axis 1 disorder for the past 12 months, excluding drug or alcohol rehabilitation
* any clinically significant chronic pain condition, as determined by the principal investigator
* positive salivary drug screen at the time of the visit, for any substance other than opiates or another prescribed medication
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02052258
Study Brief:
Protocol Section:
NCT02052258