Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00158288
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-09-08
Brief Title:
The Efficacy of Methadyl Acetate LAAM and Contingency Management Procedures for Treating Dual Opioid and Cocaine Abuse - 1
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
LAAM With Behavioral Treatment for OpioidCocaine Abuse
Status:
COMPLETED
Status Verified Date:
2005-09
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:
Although LAAM a derivative of methadone has been successfully used as an alternative to methadone maintenance in opioid addicts its effect on concurrent opioid and cocaine abuse has not been ascertained Thus this study proposes to examine the clinical efficacy of low- and high-dose LAAM maintenance on opioid and cocaine use in opioid-dependent cocaine abusers In addition since contingency management procedures have demonstrated some success in decreasing cocaine use in cocaine-abusing individuals this study also proposes to examine the clinical efficacy of the presence or absence of contingency management procedures targeting illicit drug use
Detailed Description:
One hundred forty male and female opioid-dependent cocaine abusers will be stratified by sex and randomly assigned to one of four treatment groups according to a 2 x 2 experimental design low-dose LAAM 99 mgwk with adjunct contingency management procedures low-dose LAAM 99 mgwk without adjunct contingency management procedures high-dose LAAM 330 mgwk with adjunct contingency management procedures and high-dose LAAM 330 mgwk without adjunct contingency management procedures The duration of the study will be 24 weeks with LAAM being administered on a thrice-weekly MWF basis
Subjects are inducted onto LAAM during weeks 1-3 and then maintained on their assigned maintenance dose 99 mgwk or 330 mgwk through week 24 During maintenance the Friday dose will be 13 times greater than the Monday and Wednesday dose At the conclusion of the study subjects undergo detoxification from LAAM over a 4-week period For those in the contingency management procedure group each drug-free urine submitted will result in a voucher worth a certain monetary value that increases for consecutively drug-free urines weeks 1-12 or a monetary voucher with a fixed value weeks 13-24 Subjects not assigned to the contingency management procedure will receive monetary vouchers weeks 1-24 according to a yoked-control schedule that is not contingent upon illicit drug abstinence Vouchers can be exchanged for mutually agreed upon goods and services at any time during the study Outcome measures will include 1 treatment retention 2 illicit drug use 3 self-reported adverse and opioid withdrawal symptoms and 4 psychosocial functioning Follow-up interviews at nine months andor one year post-study entry will be conducted to determine status post-treatment Prognostic factors ie sex post-traumatic stress disorder and depression will also be examined in relation to treatment outcome and post-treatment status
Subjects are inducted onto LAAM during weeks 1-3 and then maintained on their assigned maintenance dose 99 mgwk or 330 mgwk through week 24 During maintenance the Friday dose will be 13 times greater than the Monday and Wednesday dose At the conclusion of the study subjects undergo detoxification from LAAM over a 4-week period For those in the contingency management procedure group each drug-free urine submitted will result in a voucher worth a certain monetary value that increases for consecutively drug-free urines weeks 1-12 or a monetary voucher with a fixed value weeks 13-24 Subjects not assigned to the contingency management procedure will receive monetary vouchers weeks 1-24 according to a yoked-control schedule that is not contingent upon illicit drug abstinence Vouchers can be exchanged for mutually agreed upon goods and services at any time during the study Outcome measures will include 1 treatment retention 2 illicit drug use 3 self-reported adverse and opioid withdrawal symptoms and 4 psychosocial functioning Follow-up interviews at nine months andor one year post-study entry will be conducted to determine status post-treatment Prognostic factors ie sex post-traumatic stress disorder and depression will also be examined in relation to treatment outcome and post-treatment status
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 |
|---|---|---|---|
| R01-09876-1 | None | None | None |