Opioid-Related Disorders Clinical Trial
Official title:
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-2
Verified date | May 2017 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess the abuse liability and reinforcing effects of intravenous buprenorphine and buprenorphine/naloxone combinations in heroin-dependent volunteers
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 1999 |
Est. primary completion date | November 1999 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: Individuals must be at least 18 yrs of age, currently opioid dependent and must not be seeking treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency and have a history of IV opioid use. Exclusion Criteria: Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation. |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Health Sciences Center | Denver | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Subjective dose estimate | |||
Primary | Observed withdrawal rating | |||
Primary | Opioid antagonist rating | |||
Primary | Pupil diameter | |||
Primary | Analog rating scale for drug effects | |||
Primary | Drug effect characteristics | |||
Primary | Drug/Money Preferences |
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