Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Piscataway, New Jersey 08854


Purpose:

The purpose of this study is to assess buprenorphine/naloxone versus clonidine for outpatient opiate detoxification.


Study summary:

Patients randomized to the BUP/NX arm will receive daily doses for 13 days with sublingual administration of 2 mg buprenorphine/0.5 mg naloxone tablet(s) and/or an 8 mg buprenorphine/2.0 mg naloxone tablet(s). The starting dose on day 1 is 4 mg/1 mg BUP/NX with an additional 4 mg/1 mg, if needed, escalating in a step-wise manner to 16 mg/4 mg BUP/NX on day 3 and tapering to 2 mg/ 0.5 mg BUP/NX by days 12 to 13. Patients randomized to the clonidine arm will receive oral clonidine (0.05 to 0.1 mg depending upon weight) every 4 to 6 hours for 24 hours not to exceed 0.6 mg total on day 1. On day 2, a clonidine transdermal patch will be applied (0.1 mg/day/7-day patch with number of patches adjusted by weight). Oral clonidine will continue to be given on the second day of detoxification and increased to 0.2 mg every 6 hours or 0.1 mg every 3 hours not to exceed 0.8 mg over 24 hours. Patches will be worn all 13 days of detoxification. The dose of clonidine will be adjusted according to the proposed detoxification schedule, patient's weight, tolerance, and systolic blood pressure. Patients will receive counseling according to procedures in existence at each CTP throughout the study. Self-help detoxification handbooks will be distributed to all study participants.


Criteria:

Inclusion Criteria: 1. Treatment-seeking males and non-pregnant and non-lactating females, 15 years and older, who fulfill DSM-IV criteria for opiate dependence, report experiencing symptoms of opiate withdrawal, are currently physically dependent on opioids and are in need of medical assistance for opioid withdrawal. 2. Systolic blood pressure 100 mm Hg, and pulse 56 bpm. 3. Good general health or, in case of a medical/psychiatric condition needing ongoing treatment, under the care of a physician willing to continue patient's medical management and cooperate with the study physicians. 4. Agreeable to and capable of signing the informed consent approved by an institutional review board and, if under the age of 18 (excluding emancipated minors), assent and concurrent consent from a parent or legal guardian. 5. Use of one of the following acceptable methods of birth control by female patients of childbearing potential: 1. oral contraceptives 2. barrier (diaphragm or cervical cap) with spermicide or condom 3. intrauterine progesterone contraceptive system 4. levonorgestrel implant 5. medroxyprogesterone acetate contraceptive injection 6. complete abstinence from sexual intercourse Exclusion Criteria: 1. Medical condition that would make participation, in the opinion of the study physician, medically hazardous (e.g., acute hepatitis, unstable cardiovascular, liver or renal disease); 2. Clinically significant abnormalities in ECG. 3. Known allergy or sensitivity to buprenorphine, naloxone, or clonidine. 4. Receiving beta-blockers, calcium channel blockers, tricyclics, digitalis and other medications which may interact adversely with clonidine. 5. Acute severe psychiatric condition in need of immediate treatment, or imminent suicide risk. 6. Dependence on alcohol, benzodiazepines or other depressants, or stimulants, and requiring immediate medical attention. 7. Participation in an investigational drug study, including buprenorphine, within the past 30 days. 8. Methadone or LAAM maintenance or detoxification within 30 days of enrollment. 9. Pending legal action that could prohibit or interfere with participation. 10. Unable to remain in area for duration of active phase of treatment. 11. Females that are pregnant, lactating, or planning to become pregnant.


Study is Available At:


Original ID:

NIDA-CTN-0002-1


NCT ID:

NCT00032968


Secondary ID:


Study Acronym:


Brief Title:

Buprenorphine/Naloxone Versus Clonidine for Outpatient Opiate Detoxification - 1


Official Title:

Buprenorphine/Naloxone Versus Clonidine For Out-patient Opiate Detoxification


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

15 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute on Drug Abuse (NIDA)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Masking: Open Label, Prima


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

341


Enrollment Type:


Overall Contact Information

Official Name:Walter Ling, M.D.
Principal Investigator
Los Angeles Treatment Research Center

Study Dates

Start Date:January 2001
Completion Date:August 2002
Completion Type:Actual
Primary Completion Date:August 2002
Primary Completion Type:Actual
Verification Date:April 2010
Last Changed Date:January 11, 2017
First Received Date:April 5, 2002

Study Outcomes

Outcome Type:Primary Outcome
Measure:Adverse effect measures
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Decreased frequency of HIV related behavior
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Drug craving
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Adverse events
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Opiate craving
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Degree of drug craving
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Drug use
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Buprenorphine/naloxone

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, Los Angeles

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.