Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00142909
Status:
COMPLETED
Last Update Posted:
2015-07-30
First Post:
2005-09-01
Brief Title:
Effectiveness of Lofexidine to Prevent Stress-Related Opiate Relapse During Naltrexone Treatment - 1
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Lofexidine Enhancing Naltrexone Treatment for Opiate Addiction
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Lofexidine is an experimental medication that may be beneficial in reducing opiate withdrawal symptoms such as sleep difficulty anxiety and tension The purpose of this study is to determine whether lofexidine in combination with naltrexone can improve an individuals ability to cope with stress and subsequently increase the chances of remaining abstinent from opiates
Detailed Description:
Naltrexone is a medication currently used to treat opiate dependence Naltrexone blocks the euphoric effects of opiates However naltrexone treatment suffers from high rates of drop-out and relapse One possible explanation for this is that opiate addicts continue to experience stress in early recovery from opiate dependence Lofexidine is an experimental medication currently used in the United Kingdom for opiate detoxification and to treat opiate withdrawal symptoms including sleep difficulty muscle pain anxiety and tension The purpose of this study is to examine whether lofexidine in combination with naltrexone can improve an individuals ability to cope with stress The study will examine whether this in turn increases the likelihood that an individual remains abstinent from opiates and maintains recovery for a longer time period
Participants in this 12-week double-blind placebo-controlled trial will be randomly assigned to receive either lofexidine or placebo while currently receiving standard naltrexone outpatient treatment Lofexidine will be initiated at twice daily doses of 04 mg and increased to 08 mg by the end of Week 1 The doses will be increased to 12 mg by the end of Week 2 and maintained at this level for Weeks 3 through 12 During Week 12 lofexidine discontinuation will be tapered over 4 days Hour-long study visits will occur 3 times each week to assess vital signs medication side effects and withdrawal symptoms Blood alcohol and urine tests will be performed as well as a psychiatric evaluation Administration of naltrexone will also occur 3 times each week Follow-up visits will occur at Months 1 and 3 after discontinuation of lofexidine
Participants in this 12-week double-blind placebo-controlled trial will be randomly assigned to receive either lofexidine or placebo while currently receiving standard naltrexone outpatient treatment Lofexidine will be initiated at twice daily doses of 04 mg and increased to 08 mg by the end of Week 1 The doses will be increased to 12 mg by the end of Week 2 and maintained at this level for Weeks 3 through 12 During Week 12 lofexidine discontinuation will be tapered over 4 days Hour-long study visits will occur 3 times each week to assess vital signs medication side effects and withdrawal symptoms Blood alcohol and urine tests will be performed as well as a psychiatric evaluation Administration of naltrexone will also occur 3 times each week Follow-up visits will occur at Months 1 and 3 after discontinuation of lofexidine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DPMC | None | None | None |
| R01-18219-1 | None | None | None |