Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00218530
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-09-16
Brief Title:
Effectiveness of Naltrexone and Lofexidine in Treating Detoxified Heroin Addicts - 1
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Naltrexone and Lofexidine in Detoxified Heroin Addicts
Status:
COMPLETED
Status Verified Date:
2016-10
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:
Stress is one of the more common reasons cited by addicts for continual drug use and relapse Treatment approaches that target both drug-induced and stress-induced relapse may prove to be more beneficial than targeting drug-induced relapse alone Lofexidine is a drug that reduces the physical symptoms of opiate withdrawal and may prove to have stress-reducing capabilites in drug addicts The purpose of this study is to determine the maximal safe dose of lofexidine tolerated in naltrexone-treated heroin addicts and to find an optimal lofexidine induction schedule
Detailed Description:
Stress is one of the more common reasons cited by addicts for continual drug use and relapse Naltrexone treatment of opiate addicts suffers from high rates of drop-out and relapse This may be a result of naltrexones inability to reduce symptoms of stress during early recovery Treatment approaches that target both drug-induced and stress-induced relapse may prove to be more beneficial than targeting drug-induced relapse alone Lofexidine is a drug that reduces the physical symptoms of opiate withdrawal and may prove to have stress-reducing capabilities The purpose of this study is to determine the maximal safe dose of lofexidine tolerated in naltrexone-treated opiate addicts and to find an optimal lofexidine induction schedule The study will also assess any side effects that occur during a discontinuation phase of lofexidine
This pilot study will last a total of 8 weeks Recently detoxified opiate dependent participants who are eligible for naltrexone treatment will enter a 4-week single-blind dose tolerability phase during which participants will receive naltrexone and 1 of 3 twice-daily lofexidine induction schedules All participants will be required to remain in the clinic for 2 hours immediately following dosing in order to monitor vital signs and side effects Study visits will occur three times each week at which time naltrexone medication for self-administration will be handed out and participants will be evaluated in terms of tolerability to treatment After the 4 weeks of treatment a double-blind lofexidine detoxification phase using a 5-day taper will occur Participants will be randomly assigned to one of two maintenance-taper schedules The first group will undergo a 5-day tapering followed by a placebo for three weeks followed by a 5-day tapering during Week 4 Withdrawal symptoms and side effects will be evaluated
This pilot study will last a total of 8 weeks Recently detoxified opiate dependent participants who are eligible for naltrexone treatment will enter a 4-week single-blind dose tolerability phase during which participants will receive naltrexone and 1 of 3 twice-daily lofexidine induction schedules All participants will be required to remain in the clinic for 2 hours immediately following dosing in order to monitor vital signs and side effects Study visits will occur three times each week at which time naltrexone medication for self-administration will be handed out and participants will be evaluated in terms of tolerability to treatment After the 4 weeks of treatment a double-blind lofexidine detoxification phase using a 5-day taper will occur Participants will be randomly assigned to one of two maintenance-taper schedules The first group will undergo a 5-day tapering followed by a placebo for three weeks followed by a 5-day tapering during Week 4 Withdrawal symptoms and side effects will be evaluated
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DPMC | None | None | None |
| P50-18197-1 | None | None | None |