- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00158197
Long-term Behavior Change - 1
August 11, 2015 updated by: Friends Research Institute, Inc.
Behavior Change: Reinforcement Schedule Effects
The purpose of this study is to determine if different reinforcement procedures (i.e., schedules) produce different patterns of long-term abstinence from methamphetamine.
We anticipate that the three contingency management conditions will promote longer periods of abstinence in the year following treatment relative to the standard control group.
Furthermore, we predict that the intermittent reinforcement procedures will produce longer periods of continued abstinence (i.e., long-term behavior change) in the year following treatment than the continuous reinforcement procedure.
Finally, we predict that the intermittent unpredictable schedule will produce longer lasting behavior change than the intermittent predictable schedule.
Methamphetamine use will be measured using urine toxicology and self-report of methamphetamine use.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Briefly the four study conditions are: (1) standard treatment which consists of 16 weeks of psychosocial treatment, (2) continuous contingency management which consists of 16 weeks of psychosocial treatment with a contingency management procedure in effect during the first twelve weeks in which vouchers are made available after each provision of a methamphetamine-negative urine test, (3) intermittent predictable contingency management which consists of 16 weeks of psychosocial treatment with a contingency management procedure in effect during the first twelve weeks in which vouchers are available after the provision of every three consecutive methamphetamine-negative urine samples, and (4) intermittent unpredictable contingency management which consists of 16 weeks of psychosocial treatment with a contingency management procedure in effect during the first twelve weeks in which vouchers are available on one day each week (randomly selected after the first week) for the provision of methamphetamine-negative urine samples provided all urine samples since delivery of the last reinforcer were also methamphetamine negative.
Study Type
Interventional
Enrollment (Actual)
119
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90025
- Friends Research Institute
-
Rancho Cucamonga, California, United States, 91730
- Friends Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for methamphetamine dependence
- Willing and able to comply with study procedures
- Willing and able to provide written informed consent
Exclusion Criteria:
- Have a medical condition that, in the study Principal Investigator (PI's) judgment, might interfere with safe study participation
- Have a recent (past 30 days) history of suicide attempts and/or current serious suicidal intention or plan as assessed by the Beck Depression Inventory (BDI)
- Have a history of violent criminal behavior or be on parole
- Any other circumstances that, in the opinion of the PI, would interfere with safe study participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: continuous voucher schedule
Those in the continuous condition will receive a contingency management voucher each time they test negative for methamphetamine.
The initial voucher value will be $2.50.
Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50.
Three consecutive abstinences will result in the delivery of a $10.00 bonus.
Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.
All participants will provide observed urine samples three times a week (e.g., M, W, & F) for twelve weeks and will complete study-related measures one time per week.
|
participants receive vouchers for the provision of methamphetamine-negative urines.
Vouchers can be redeemed for goods and services compatible with non-drug using behaviors.
|
Experimental: intermittent predictable schedule
Those in the intermittent predictable condition will earn a contingency management voucher when they provide three consecutive methamphetamine-negative urine tests.
Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth.
There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition.
Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.
All participants will provide observed urine samples three times a week (e.g., M, W, & F) for twelve weeks and will complete study-related measures one time per week.
|
participants receive vouchers for the provision of methamphetamine-negative urines.
Vouchers can be redeemed for goods and services compatible with non-drug using behaviors.
|
Experimental: intermittent unpredictable schedule
Those in the intermittent unpredictable condition will be eligible to receive a contingency management voucher on one day a week.
Participants in this group will receive a voucher for $22.00 following their first 3 methamphetamine-negative urine tests.
They will then be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative.
They will receive a voucher for $35.50 for the provision of their second set of 3 consecutive instances of methamphetamine-negative urine samples, $49.00 for their third set of 3 consecutive instances, and so forth.
The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test.
All participants will provide observed urine samples M, W, & F for 12 wks and complete measures 1x/wk.
|
participants receive vouchers for the provision of methamphetamine-negative urines.
Vouchers can be redeemed for goods and services compatible with non-drug using behaviors.
|
No Intervention: standard
Participants assigned to the standard condition will not receive vouchers for the provision of clean urines.
All participants will provide observed urine samples three times a week (e.g., M, W, & F) for twelve weeks and will complete study-related measures one time per week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Methamphetamine Use During Intervention
Time Frame: 3x/week for 16 weeks
|
Drug use measured by urine toxicology conducted by on site Enzyme-multiplied immunoassay technique (EMIT) assay over time.
|
3x/week for 16 weeks
|
Methamphetamine Use, Measured by Number of Consecutive Days of Abstinence
Time Frame: 16 Weeks
|
Drug use measured by urine toxicology conducted by on site EMIT assay and added up to obtain how many days of consecutive abstinence were observed for each individual
|
16 Weeks
|
Methamphetamine Use, Follow-Up
Time Frame: 1x/month for 4 months
|
Drug use measured by urine toxicology conducted by on site EMIT assay over time
|
1x/month for 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: John Roll, Ph.D., University of California, Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2004
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 8, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Estimate)
August 25, 2015
Last Update Submitted That Met QC Criteria
August 11, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIDA-17407-1
- R01DA017407 (U.S. NIH Grant/Contract)
- R01-17407-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Amphetamine-related Disorders
-
National Taiwan University HospitalUnknownMethamphetamine Dependence | Methamphetamine Abuse | Amphetamine Dependence | Amphetamine AbuseTaiwan
-
University of PennsylvaniaNational Institute on Drug Abuse (NIDA); Society of Alcoholism and other AddictionsCompletedAmphetamine DependenceIceland
-
Shanghai Mental Health CenterCompletedAmphetamine AddictionChina
-
Shanghai Mental Health CenterRecruitingAmphetamine AddictionChina
-
Centre hospitalier de l'Université de Montréal...Withdrawn
-
Shanghai Mental Health CenterCompleted
-
University of VirginiaAmerican Association of Chairs of Departments of PsychiatryWithdrawnAmphetamine DependenceUnited States
-
The University of New South WalesSt Vincent's Hospital, Sydney; Australian Government Department of Health and... and other collaboratorsUnknown
-
California Pacific Medical Center Research InstituteUnknownSubstance Dependence | Amphetamine DependenceUnited States
-
Universiti Sains MalaysiaYale UniversityUnknownHeroin Dependence | Amphetamine DependenceMalaysia
Clinical Trials on contingency management voucher
-
University of VermontCompleted
-
University of California, Los AngelesCompletedHIV Infections | Substance Abuse
-
University of WashingtonNational Institute on Drug Abuse (NIDA)CompletedHIV | Sexual Behavior | Methamphetamine | Behavioral ResearchUnited States
-
Wayne State UniversityNational Institute on Drug Abuse (NIDA)Completed
-
VA Office of Research and DevelopmentRecruitingPTSD | Cannabis-Related DisorderUnited States
-
Johns Hopkins UniversityJohns Hopkins Community PhysiciansWithdrawnSubstance-related DisorderUnited States
-
University of California, Los AngelesCompleted
-
UConn HealthNational Institute on Drug Abuse (NIDA)Completed
-
UConn HealthNational Institute on Drug Abuse (NIDA)Completed
-
UConn HealthNational Institute on Drug Abuse (NIDA)Completed