Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00292136
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
2006-02-14
Brief Title:
Real Time Assessment of Drug Craving Use and Abstinence During Outpatient A Development and Feasibility Study
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Real Time Assessment of Drug Craving Use and Abstinence During Outpatient A Development and Feasibility Study
Status:
COMPLETED
Status Verified Date:
2013-06-11
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
The treatment of addiction often hinges on preventing relapse into drug-using behaviors which occurs at high rates even after prolonged abstinence Research has shown that constant reporting through personal data-collection devices such as electronic diaries can help prevent relapse and reinforce abstinence This constant reporting is known as Ecological Momentary Assessment EMA
The researchers here at NIDA have already completed two major arms of the study focusing on patterns of craving and drug use during methadone maintenance and on whether electronic diaries could help remind outpatients to complete treatment tasks An ongoing arm of the study is examining connections among drug cravinguse stress and geographical location
Objective
- To investigate the role of stress associated with geographical location in drug craving and use
Eligibility
- Individuals between 18 and 65 years of age or older who are dependent on opioids cocaine andor heroin
Design
The study will last 28 weeks After the initial screening participants will receive daily methadone and weekly drug counseling sessions that will continue throughout the study
After 3 weeks of methadone treatment participants will have 15 weeks of EMA in which they will record both event-triggered cravings and daily responses 3 per day EMA will consist of event-triggered recordings initiated by participants whenever they use heroin or cocaine or whenever they feel an urge to do so and random-signal-triggered recordings 3 per day During EMA participants will begin a voucher-based program to encourage abstinence from heroin and cocaine
Participants will also carry global positioning system GPS units to record their locations during these 15 weeks and will complete questionnaires about stress levels at specific intervals during the study
At the end of the study participants will have the choice of transferring to a community clinic or undergoing an 8-week taper from methadone
The treatment of addiction often hinges on preventing relapse into drug-using behaviors which occurs at high rates even after prolonged abstinence Research has shown that constant reporting through personal data-collection devices such as electronic diaries can help prevent relapse and reinforce abstinence This constant reporting is known as Ecological Momentary Assessment EMA
The researchers here at NIDA have already completed two major arms of the study focusing on patterns of craving and drug use during methadone maintenance and on whether electronic diaries could help remind outpatients to complete treatment tasks An ongoing arm of the study is examining connections among drug cravinguse stress and geographical location
Objective
- To investigate the role of stress associated with geographical location in drug craving and use
Eligibility
- Individuals between 18 and 65 years of age or older who are dependent on opioids cocaine andor heroin
Design
The study will last 28 weeks After the initial screening participants will receive daily methadone and weekly drug counseling sessions that will continue throughout the study
After 3 weeks of methadone treatment participants will have 15 weeks of EMA in which they will record both event-triggered cravings and daily responses 3 per day EMA will consist of event-triggered recordings initiated by participants whenever they use heroin or cocaine or whenever they feel an urge to do so and random-signal-triggered recordings 3 per day During EMA participants will begin a voucher-based program to encourage abstinence from heroin and cocaine
Participants will also carry global positioning system GPS units to record their locations during these 15 weeks and will complete questionnaires about stress levels at specific intervals during the study
At the end of the study participants will have the choice of transferring to a community clinic or undergoing an 8-week taper from methadone
Detailed Description:
Background We have already completed the original major arm of this protocol a natural-history study of craving and lapse Still open for enrollment is the second minor arm a within-subject trial of PDA-based treatment-task reminders In the third arm there will be enhanced assessment of mood stress and geographical location to further study craving and lapse All arms of the study have developed from either or both of two aspects of the original arm 1 Our growing appreciation of the technical possibilities of electronic data collection in participants daily environments and 2 our growing interest in having participants provide descriptive data about the day-to-day experience of addiction and recovery
The major completed arm of the protocol has provided a wealth of descriptive data on drug craving and lapse via Ecological Momentary Assessment EMA in which participants carry handheld data-collection devices electronic diaries EDs on which they report in real time their activities and moods Beyond data monitoring EDs can be used to complement behavioral interventions The data-collection devices can be additionally programmed to prompt completion of therapist-assigned homework exercises by extending support outside the therapy session clinical outcome may be improved Furthermore there is an evidenced association between completion of homework exercises and therapeutic outcome Adapting existing homework assignments to make them more engaging may increase homework completion and in turn general compliance with therapy Arm 2 The rationale for the third arm of the study is to broaden the perspective of the examination of the natural history of drug cravings and lapses by refining our assessments of geographical location and the stressors associated with it In doing so we intend to investigate determinants of addiction that are not reducible to individual-level traits but are instead reflective of broader socioeconomic problems manifested in differences among neighborhoods
Scientific goals Arm 1 To investigate the relationships between putative triggers and drug craving and lapse Arm 2 To investigate interactive effects of electronic-diary reminders and simplified therapy-assigned homework tasks on homework completion and therapeutic outcome Arm 3 Using refinements in our assessment methods to investigate the role of stress associated with geographical location in drug craving and use
Participant population Arm 2 35 cocaine-abusing opioid-dependent outpatients Arm 3 50 cocaine-abusing opioid-dependent outpatients separate from those in Arm 2 Target enrollment for both arms will include 40 women and 60 minorities mostly African-American
TAB
Experimental design and methods After 3 weeks of stabilization on daily methadone outpatients will undergo 25 weeks of EMA EMA will consist of event-triggered recordings initiated by participants whenever they use heroin or cocaine or whenever they feel an urge to do so and random-signal-triggered recordings 3 per day Target quit dates for heroin and cocaine will occur respectively on the first and third weeks of EMA Two days after the cocaine quit date all participants will begin 12 weeks of intensive voucher-based contingency management to reinforce abstinence from heroin and cocaine Arm 2 During the same 12 weeks a within-subjects manipulation will occur participants will receive simplified versions of the current counselor-assigned homework tasks and participants will receive a daily reminder via the PDA to complete their homework tasks whether they are standard or simplified versions The simplified homework tasks and reminders will be given during two separate counterbalanced three-week blocks Arm 3 Starting at week 4 and continuing through week 18 participants will answer enhanced EMA questions regarding stress mood location drug craving and use Additionally participants in Arm 3 will carry GPS units to record their locations during these 15 weeks GPS location will be examined with their drug use craving and self-reported mood They will also complete retrospective stress questionnaires at week 3 and then at 4-week intervals throughout the completion of the study week 7 11 15 19 23 and 27 After the 12-week homework Arm 2 or enhanced EMA phase Arm 3 ends participants will have the choice of transferring to a community clinic or undergoing an eight-week taper from methadone For participants in Arm 2 who choose to detox at Archway EMA may continue However for participants in Arm 3 no EMA or GPS data will be collected during the pre-detox or detox phase weeks 19-28
TAB
Benefits to participants andor society Direct benefits to participants include psychological and pharmacologic assistance for decreasing illicit drug use The methadone administered during the study will decrease the participants intravenous opiate use The contingency management and psychotherapy procedures may further reduce drug use and HIV risk behaviors The decrease in HIV risk behaviors should result in lower incidence of HIV disease Benefits to society include an increase in scientific understanding of the precipitants and process of craving lapse and relapse and an improvement in our ability to assess the clinical effectiveness of relapse-prevention medications in future clinical trials
TAB
Risks to participants Participants on methadone may experience side effects of sedation constipation or mild euphoria The risks of overmedication will be reduced by gradually increasing the dose of methadone over the first week The methadone dose used in Arm 2 of this protocol 100 mg is within the limits allowed by the FDA guidelines and within the dose range used in methadone clinics in Baltimore For Arm 3 of the protocol there is no ceiling methadone dose Methadone doses will be adjusted by the MRP as clinically indicated based on participant feedback withdrawal signssymptoms reported cravings and urine toxicology results If a patient shows signs of intoxication the MRP will reduce the methadone dose until evidence of intoxication has subsided Methadone will be discontinued if a participant experiences severe side effects Participants who are withdrawn from methadone will experience opiate withdrawal symptoms but these symptoms will be minimized by the long detox period of 8 to 12 weeks Other risks are the inconvenience of carrying and using the EDs and possible embarrassment from providing urine samples under observation and concern about the collection of GPS data
The major completed arm of the protocol has provided a wealth of descriptive data on drug craving and lapse via Ecological Momentary Assessment EMA in which participants carry handheld data-collection devices electronic diaries EDs on which they report in real time their activities and moods Beyond data monitoring EDs can be used to complement behavioral interventions The data-collection devices can be additionally programmed to prompt completion of therapist-assigned homework exercises by extending support outside the therapy session clinical outcome may be improved Furthermore there is an evidenced association between completion of homework exercises and therapeutic outcome Adapting existing homework assignments to make them more engaging may increase homework completion and in turn general compliance with therapy Arm 2 The rationale for the third arm of the study is to broaden the perspective of the examination of the natural history of drug cravings and lapses by refining our assessments of geographical location and the stressors associated with it In doing so we intend to investigate determinants of addiction that are not reducible to individual-level traits but are instead reflective of broader socioeconomic problems manifested in differences among neighborhoods
Scientific goals Arm 1 To investigate the relationships between putative triggers and drug craving and lapse Arm 2 To investigate interactive effects of electronic-diary reminders and simplified therapy-assigned homework tasks on homework completion and therapeutic outcome Arm 3 Using refinements in our assessment methods to investigate the role of stress associated with geographical location in drug craving and use
Participant population Arm 2 35 cocaine-abusing opioid-dependent outpatients Arm 3 50 cocaine-abusing opioid-dependent outpatients separate from those in Arm 2 Target enrollment for both arms will include 40 women and 60 minorities mostly African-American
TAB
Experimental design and methods After 3 weeks of stabilization on daily methadone outpatients will undergo 25 weeks of EMA EMA will consist of event-triggered recordings initiated by participants whenever they use heroin or cocaine or whenever they feel an urge to do so and random-signal-triggered recordings 3 per day Target quit dates for heroin and cocaine will occur respectively on the first and third weeks of EMA Two days after the cocaine quit date all participants will begin 12 weeks of intensive voucher-based contingency management to reinforce abstinence from heroin and cocaine Arm 2 During the same 12 weeks a within-subjects manipulation will occur participants will receive simplified versions of the current counselor-assigned homework tasks and participants will receive a daily reminder via the PDA to complete their homework tasks whether they are standard or simplified versions The simplified homework tasks and reminders will be given during two separate counterbalanced three-week blocks Arm 3 Starting at week 4 and continuing through week 18 participants will answer enhanced EMA questions regarding stress mood location drug craving and use Additionally participants in Arm 3 will carry GPS units to record their locations during these 15 weeks GPS location will be examined with their drug use craving and self-reported mood They will also complete retrospective stress questionnaires at week 3 and then at 4-week intervals throughout the completion of the study week 7 11 15 19 23 and 27 After the 12-week homework Arm 2 or enhanced EMA phase Arm 3 ends participants will have the choice of transferring to a community clinic or undergoing an eight-week taper from methadone For participants in Arm 2 who choose to detox at Archway EMA may continue However for participants in Arm 3 no EMA or GPS data will be collected during the pre-detox or detox phase weeks 19-28
TAB
Benefits to participants andor society Direct benefits to participants include psychological and pharmacologic assistance for decreasing illicit drug use The methadone administered during the study will decrease the participants intravenous opiate use The contingency management and psychotherapy procedures may further reduce drug use and HIV risk behaviors The decrease in HIV risk behaviors should result in lower incidence of HIV disease Benefits to society include an increase in scientific understanding of the precipitants and process of craving lapse and relapse and an improvement in our ability to assess the clinical effectiveness of relapse-prevention medications in future clinical trials
TAB
Risks to participants Participants on methadone may experience side effects of sedation constipation or mild euphoria The risks of overmedication will be reduced by gradually increasing the dose of methadone over the first week The methadone dose used in Arm 2 of this protocol 100 mg is within the limits allowed by the FDA guidelines and within the dose range used in methadone clinics in Baltimore For Arm 3 of the protocol there is no ceiling methadone dose Methadone doses will be adjusted by the MRP as clinically indicated based on participant feedback withdrawal signssymptoms reported cravings and urine toxicology results If a patient shows signs of intoxication the MRP will reduce the methadone dose until evidence of intoxication has subsided Methadone will be discontinued if a participant experiences severe side effects Participants who are withdrawn from methadone will experience opiate withdrawal symptoms but these symptoms will be minimized by the long detox period of 8 to 12 weeks Other risks are the inconvenience of carrying and using the EDs and possible embarrassment from providing urine samples under observation and concern about the collection of GPS data
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 |
|---|---|---|---|
| 03-DA-N385 | None | None | None |