Opioid Dependency
Conditions
Keywords
opioid dependence, opioid addiction, buprenorphine, implant, methadone, heroin, suboxone, opioid pain medication, opioid withdrawal
Brief summary
Probuphine (buprenorphine implant) is an implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This study will confirm the efficacy of Probuphine vs. placebo and compare Probuphine treatment verses treatment with sublingual buprenorphine in the treatment of patients with opioid dependence.
Interventions
Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug.
DRUGplacebo implant
Implant contains ethylene vinyl acetate
DRUGBuprenorphine
sublingual buprenorphine/naloxone tablets
Sponsors
National Institute on Drug Abuse (NIDA)
Titan Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Voluntarily provide written informed consent prior to the conduct of any study-related procedures * Male or female, 18-65 years of age * Meet DSM-IV-TR criteria for current opioid dependence * Females of childbearing potential or a fertile male, must use a reliable means of contraception
Exclusion criteria
* Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS) * Received any medication-assisted treatment for opioid dependence (e.g., methadone, BPN) within the previous 90 days * Current diagnosis of chronic pain requiring opioids for treatment * Candidates for short-term opioid treatment (\<6 months) only, or opioid detoxification therapy * Pregnant or lactating female? * Previous hypersensitivity or allergy to BPN, EVA-containing substances, or naloxone * Current use of agents metabolized through Cytochrome P450 3A4 (CYP 3A4) such as azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), or protease inhibitors (e.g., ritonavir, indinavir, and saquinavir) * History of coagulopathy within the past 90 days, and/or current anti-coagulant therapy such as warfarin * Meet the DSM-IV-TR criteria for dependence on any other psychoactive substances other than opioids or nicotine (e.g., alcohol, sedatives) * Significant medical or psychiatric symptoms, cognitive impairment, or other factors which in the opinion of the Investigator would preclude compliance with the protocol, subject safety, adequate cooperation in the study, or obtaining informed consent * Current medical conditions such as severe respiratory insufficiency that may prevent the subject from safely participating in study, or any pending legal action that could prohibit participation or compliance in the study * Exposure to any investigational drug within the previous 8 weeks * Previous exposure to Probuphine, or prior implantation with a placebo implant in the context of a Probuphine clinical trial * Presence of aspartate aminotransferase (AST) levels greater than or equal to 3 X the upper limit of normal, alanine aminotransferase (ALT) levels greater than or equal to 3 X the upper limit of normal, total bilirubin greater than or equal to 1.5 X the upper limit of normal, or creatinine greater than 1.5 X upper limit of normal on the screening laboratory assessments * Clinically significant low platelet count on the screening laboratory assessments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CDF of the percent of urine samples negative for opioids in Probuphine and Placebo groups from weeks 1-24 | 1-24 weeks |
| CDF of the percent of urine samples negative for opioids from weeks 1-24 with imputation based on illicit drug use self-report data for Probuphine and placebo groups | 1-24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| CDF of the percent of urine samples negative for opioids from weeks 1-16 | 1-16 weeks |
| CDF of the percent of urine samples negative for opioids from weeks 17-24 | 17-24 weeks |
| Difference of proportion of urine samples negative for illicit opioids over 24 weeks of treatment for Probuphine vs. SL BPN | 24 weeks |
Other
| Measure | Time frame |
|---|---|
| Patient-rated Clinical Global Improvement (CGI) | 24 weeks |
| Physician-rated Clinical Global Improvement (CGI) | 24 weeks |
| Percent urines negative for illicit opioids | 24 weeks |
| Mean maximum period of continuous abstinence | 24 weeks |
| Mean total number of weeks of abstinence | 24 weeks |
| Percent of study completers | 24 weeks |
| Mean total score on the SOWS | 24 weeks |
| Mean total score on the COWS | 24 weeks |
| Mean subjective opioid craving assessment using Visual Analog Scale (VAS) | 24 weeks |
Countries
United States
Outcome results
None listed