Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00295308
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2006-02-22
Brief Title:
Clonidine for Relapse Prevention in Buprenorphine-Maintenance Patients
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Clonidine for Relapse Prevention in Buprenorphine-Maintenance Patients
Status:
COMPLETED
Status Verified Date:
2014-09-17
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:
Background
Though the drug buprenorphine effectively treats dependence on opioids like heroin some abstinent patients relapse to use during treatment This relapse may be triggered by stress or stressful situations and buprenorphine probably has no specific protective effect in these situations Buprenorphine probably also has no specific effect on relapse to cocaine use
Research has shown that clonidine a drug originally prescribed to treat high blood pressure and some symptoms of opioid withdrawal can help block stress-induced relapse to heroin and cocaine seeking in rats Researchers are interested in studying whether a combination of clonidine and buprenorphine may be more effective in preventing drug relapse than administering one of the medications alone
Objectives
- To determine whether clonidine given to abstinent patients maintained on buprenorphine is more effective than placebo in preventing relapse to heroin or cocaine use
Eligibility
- Individuals between 18 and 50 years of age who are current cocaine or heroin users seeking treatment
Design
The study will last up to 36 weeks with four phases of treatment and a follow-up evaluation Three times a week participants will be asked to report illicit drug use and provide urine and breath samples Throughout the study participants will receive individual counseling in weekly 40 60 minute sessions Other samples and tests will be scheduled as required by the study researchers
Patients will be stabilized on daily buprenorphine over the first 14 days of the study
Weeks 1 8 Participants will receive vouchers for regular substance-free urine samples Those who successfully complete this phase will continue to the next part of the study
Weeks 7 9 Participants will receive either clonidine or placebo along with the buprenorphine The dose of clonidine will be stabilized during this time
Weeks 9 22 Participants will continue to receive either clonidine or placebo along with the buprenorphine During this part of the study participants will keep electronic diaries to record drug use or craving and to record data on mood stress levels and activity
Weeks 23 28 Participants will stop taking the clonidine or placebo but will continue the buprenorphine treatment Participants will continue to keep electronic diaries
Weeks 29 36 Participants will have the choice of transferring to a community clinic transfer or gradually reducing doses of buprenorphine to end the study
Participants will return for a follow-up visit and urine sample 6 months after the end of the study
Though the drug buprenorphine effectively treats dependence on opioids like heroin some abstinent patients relapse to use during treatment This relapse may be triggered by stress or stressful situations and buprenorphine probably has no specific protective effect in these situations Buprenorphine probably also has no specific effect on relapse to cocaine use
Research has shown that clonidine a drug originally prescribed to treat high blood pressure and some symptoms of opioid withdrawal can help block stress-induced relapse to heroin and cocaine seeking in rats Researchers are interested in studying whether a combination of clonidine and buprenorphine may be more effective in preventing drug relapse than administering one of the medications alone
Objectives
- To determine whether clonidine given to abstinent patients maintained on buprenorphine is more effective than placebo in preventing relapse to heroin or cocaine use
Eligibility
- Individuals between 18 and 50 years of age who are current cocaine or heroin users seeking treatment
Design
The study will last up to 36 weeks with four phases of treatment and a follow-up evaluation Three times a week participants will be asked to report illicit drug use and provide urine and breath samples Throughout the study participants will receive individual counseling in weekly 40 60 minute sessions Other samples and tests will be scheduled as required by the study researchers
Patients will be stabilized on daily buprenorphine over the first 14 days of the study
Weeks 1 8 Participants will receive vouchers for regular substance-free urine samples Those who successfully complete this phase will continue to the next part of the study
Weeks 7 9 Participants will receive either clonidine or placebo along with the buprenorphine The dose of clonidine will be stabilized during this time
Weeks 9 22 Participants will continue to receive either clonidine or placebo along with the buprenorphine During this part of the study participants will keep electronic diaries to record drug use or craving and to record data on mood stress levels and activity
Weeks 23 28 Participants will stop taking the clonidine or placebo but will continue the buprenorphine treatment Participants will continue to keep electronic diaries
Weeks 29 36 Participants will have the choice of transferring to a community clinic transfer or gradually reducing doses of buprenorphine to end the study
Participants will return for a follow-up visit and urine sample 6 months after the end of the study
Detailed Description:
Background Though buprenorphine effectively treats opioid dependence some abstinent patients relapse to maladaptive use of opioids during treatment Relapse may be triggered by stress Rodent studies have demonstrated that stress can induce relapse to heroin and cocaine use Erb et al 1996 Shaham et al 1996 Shaham and Stewart 1995 In a rodent model stress-induced relapse to heroin and cocaine seeking is blocked by the alpha-2 adrenergic agonist clonidine In this study clonidine will be compared to placebo in preventing relapse to opioid abuse in opioid maintained patients who have achieved abstinence while on buprenorphine and contingency management
Scientific goals To determine whether clonidine given to abstinent patients maintained on buprenorphine prevents relapse to opioid use more effectively than placebo
Participant population 300 opioid-dependent outpatients 120 evaluable Target enrollment will include 40 persent women and 60 percent minorities mostly African-American
Experimental design and methods The study will be a randomized double-blind clinical trial Two treatment groups will be studied 60group one receiving clonidine and the other receiving placebo Assignment to treatment group will be randomized All patients will receive buprenorphine daily 8 mg to 24 mg SL and individual counseling weekly throughout 28 weeks of treatment In order to establish abstinence prior to clonidine induction after one week of stabilization on buprenorphine they will receive contingent vouchers for opioid-negative urine specimens for 8 weeks weeks 1-8 Patients who are abstinent from illicit opioids during weeks 5 and 6 will be randomized to receive clonidine 03 mg oral dose or clonidine placebo from weeks 9 through 20 Participants who are not abstinent will be switched to methadone for four weeks usual dose from 50 mg to 100 mg followed by an eight week methadone taper Assignment to clonidine or placebo will be double-blind Weeks 21 and 22 will include a clonidine taper to avoid rebound hypertension From weeks 23-28 participants will receive buprenorphine and counseling only and then will be offered assistance to transfer to another program those who do not transfer will undergo an 8-week buprenorphine taper The primary outcome measures will be longest duration of opioid abstinence time to relapse and the proportion of opioid-negative urine specimens over time during the Intervention phase In addition fluctuations in drug use drug craving stress and HIV-risk behaviors such as injection drug use will be assessed via ecological momentary assessment EMA
Benefits to participants andor society Participants will receive buprenorphine drug counseling and contingency-management therapy The buprenorphine and voucher interventions are likely to reduce participants use of opioids Counseling will include reduction of HIV risk behaviors
Risks to participants Participants may experience side effects from clonidine buprenorphine or methadone and discomfort during withdrawal from each drug In particular discontinuation of clonidine may cause rebound hypertension The EMA component of the study may generate some assessment burden
Scientific goals To determine whether clonidine given to abstinent patients maintained on buprenorphine prevents relapse to opioid use more effectively than placebo
Participant population 300 opioid-dependent outpatients 120 evaluable Target enrollment will include 40 persent women and 60 percent minorities mostly African-American
Experimental design and methods The study will be a randomized double-blind clinical trial Two treatment groups will be studied 60group one receiving clonidine and the other receiving placebo Assignment to treatment group will be randomized All patients will receive buprenorphine daily 8 mg to 24 mg SL and individual counseling weekly throughout 28 weeks of treatment In order to establish abstinence prior to clonidine induction after one week of stabilization on buprenorphine they will receive contingent vouchers for opioid-negative urine specimens for 8 weeks weeks 1-8 Patients who are abstinent from illicit opioids during weeks 5 and 6 will be randomized to receive clonidine 03 mg oral dose or clonidine placebo from weeks 9 through 20 Participants who are not abstinent will be switched to methadone for four weeks usual dose from 50 mg to 100 mg followed by an eight week methadone taper Assignment to clonidine or placebo will be double-blind Weeks 21 and 22 will include a clonidine taper to avoid rebound hypertension From weeks 23-28 participants will receive buprenorphine and counseling only and then will be offered assistance to transfer to another program those who do not transfer will undergo an 8-week buprenorphine taper The primary outcome measures will be longest duration of opioid abstinence time to relapse and the proportion of opioid-negative urine specimens over time during the Intervention phase In addition fluctuations in drug use drug craving stress and HIV-risk behaviors such as injection drug use will be assessed via ecological momentary assessment EMA
Benefits to participants andor society Participants will receive buprenorphine drug counseling and contingency-management therapy The buprenorphine and voucher interventions are likely to reduce participants use of opioids Counseling will include reduction of HIV risk behaviors
Risks to participants Participants may experience side effects from clonidine buprenorphine or methadone and discomfort during withdrawal from each drug In particular discontinuation of clonidine may cause rebound hypertension The EMA component of the study may generate some assessment burden
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 |
|---|---|---|---|
| 06-DA-N407 | None | None | None |