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Home > "C" Clinical Trials Conditions > CS1008A Efficacy/Safety Trial of Buprenorphine/Naloxone - 1  CS1008A Efficacy/Safety Trial of Buprenorphine/Naloxone - 1
CS1008A Efficacy/Safety Trial of Buprenorphine/Naloxone - 1
For Condition: Substance-Related Disorders,Opioid-Related Disorders
Status: Completed
Sponsor(s): National Institute on Drug Abuse (NIDA) , Cincinnati MDRU
Synopsis: To determine the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate-dependence treatment. The developmental objective for this combination product is an expansion of therapeutic options for the treatment of opiate dependence.
Details: This multicenter pivotal clinical trial was comprised of two phases. The first phase, which was four weeks in length, was double-blind placebo controlled and was primarily used to evaluate the efficacy of buprenorphine/naloxone. The second phase, lasting 48 weeks, was primarily conducted to determine the safety of buprenorphine/naloxone.
Eligibility:
Study Type: Interventional, Treatment, Uncontrolled
Minimum Age/Maximum Age: 23 Years/59 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: 1. DSM-IV (Diagnostic and Statistical Manual of the American Psychiatric Association) diagnosis of current opiate dependence. 2. Individuals seeking opiate-substitution pharmacotherapy for opiate dependence. 3. Males and non-pregnant, non-nursing females, 18 to 59 years of age (inclusive). 4. Individuals able to give informed consent and willing to comply with all study procedures (e.g., providing of urine samples under observation, completing questionnaires). Exclusion Criteria: 1. Any acute or chronic medical condition that would make participation in the study medically hazardous (e.g., acute hepatitis, unstable cardiovascular, hepatic, or renal disease, unstable diabetes, symptomatic AIDS; not HIV-seropositivity alone). 2. Aspartate or alanine aminotransferase (AST, ALT) levels greater than three times the upper limit of normal. 3. Individuals currently taking systemic anti-retroviral or anti-fungal therapy. 4. Current dependence (by DSM-IV criteria) on any psychoactive substance other than opiates, caffeine, or nicotine. 5. Current, primary, Axis I psychiatric diagnosis other than opiate, caffeine, or nicotine dependence. 6. Females of childbearing potential who do not agree to use a medically acceptable method of birth control. Acceptable methods include a) oral contraceptive, b) barrier (diaphragm or condom) - a spermicide is not required due to the possib ility of local irritation and allergic type reactions, but are recommended for use, c) levonorgestrel implant, d) intrauterine progesterone contraceptive system, e) medroxyprogesterone acetate contraceptive injection, or f) complete abstinence. 7. Enrollment in an opiate-substitution (i.e., methadone, levo-alpha-acetylmethadol) treatment program within 45 days of enrolling in the present study. 8. Individuals having taken (licitly or illicitly) LAAM, methadone, or naltrexone within days of enrolling in the present study. 9. Individuals having taken buprenorphine, other than as an analgesic, within 365 days of enrolling in the present study. 10. Participation in an investigational drug or device study within 45 days of enrolling in the present study. 11. Anyone, who in the opinion of site principal investigator, would not be expected to complete the first phase of the study protocol (e.g., due to pending incarceration or probable relocation from the clinic area).
Total Enrollment: 0
Location and Contact Information:
Overall Study Official:
EugeneSomoza, Principal Investigator, Cincinnati MDRU
Cincinnati MDRU
Cincinnati, Ohio, 45220
United States
Additional Information:
Study ID Numbers: NIDA-5-0012-1;
Study Start Date: November 1996
Record last reviewed: November 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00015028
Other Substance-Related Disorders Studies:
1. Motivational Incentives for Enhanced Drug Abuse Recovery: Drug Free Clinics - 1
2. Safety Evaluation of Lofexidine for Treatment of Opioid Withdrawal - 3
3. Modeling Impaired Judgement in Cocaine Abusers - 6
4. Effects of Behavioral Contingencies on Effects of Nitrous Oxide - 12
5. Differential Acute Tolerance Development to Effects of Nitrous Oxide - 7
Related Studies:
Other Substance-Related Disorders Clinical Trials
Other Ohio Clinical Trials
Other Cincinnati Clinical Trials
CS1008A Efficacy/Safety Trial of Buprenorphine/Naloxone - 1
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