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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA017407 | U.S. NIH Grant/Contract | View source | |
| R01-17407-1 |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| continuous voucher schedule | Experimental | 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. |
|
| intermittent predictable schedule | Experimental | 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. |
|
| intermittent unpredictable schedule | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| contingency management voucher | Behavioral | participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors. |
| Measure | Description | Time Frame |
|---|---|---|
| Methamphetamine Use During Intervention | 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 | 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 | Drug use measured by urine toxicology conducted by on site EMIT assay over time | 1x/month for 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Roll, Ph.D. | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Friends Research Institute | Los Angeles | California | 90025 | United States | ||
| Friends Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23708468 | Result | Roll JM, Chudzynski J, Cameron JM, Howell DN, McPherson S. Duration effects in contingency management treatment of methamphetamine disorders. Addict Behav. 2013 Sep;38(9):2455-62. doi: 10.1016/j.addbeh.2013.03.018. Epub 2013 Apr 3. |
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The main reasons individuals were excluded from the trial prior to group assignment was not meeting inclusion criteria and discontinuing treatment prior to randomization.
Recruitment and enrollment began in January 2005 and ended . Individuals were recruited from the community via radio and newspaper ads, flyers, and word of mouth.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intermittent Predictable Schedule | Those in the intermittent predictable condition earned a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition received $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 were no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, resulted in a reset in the voucher magnitude back to its original level from whence the progression can begin again. contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors. |
| FG001 | Continuous Schedule | Those in the continuous condition received a voucher each time they tested negative for methamphetamine. The initial voucher value was $2.50. Each consecutive instance of abstinence increased the magnitude of the voucher by $1.50. Three consecutive abstinences resulted in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, resulted in a reset in the voucher magnitude back to its original level from whence the progression could begin again. contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors. |
| FG002 | Intermittent Unpredictable Schedule | Participants in the unpredictable intermittent condition earned vouchers of the same magnitude as those in the predictable intermittent condition and at approximately the same rate (i.e., $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second week of methamphetamine-negative urines, etc). More specifically, participants in this group received a voucher for $22.00 following their first three methamphetamine-negative urine tests. Following that they were 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. This date was randomly determined and they did not know in advance what day it was. contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors. |
| FG003 | Standard | Participants assigned to the standard condition did not receive vouchers for the provision of clean urines. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intermittent Predictable Schedule | Those in the intermittent predictable condition will earn a 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. contingency managment voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Methamphetamine Use During Intervention | Drug use measured by urine toxicology conducted by on site Enzyme-multiplied immunoassay technique (EMIT) assay over time. | All individuals randomized were included in the analysis (i.e., intention to treat). | Posted | Number | percentage of negative urine samples | 3x/week for 16 weeks | Urine samples | Participants |
|
Adverse Event data were collected at each study and follow-up visit, for 1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| slipped vertebral disk | Musculoskeletal and connective tissue disorders | Systematic Assessment | Pain and stiffness in neck.Diagnosed with a slipped vertebral disk and underwent surgery to correct it. Ct was prescribed painkillers and assigned physical therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| eye surgery | Eye disorders | Systematic Assessment | Ct reported undergoing surgery on left eye to remove cataract. Ct was released the same day with a prescription for steroid eye drops. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joy Chudzynski | Friends Research Institute | 323-333-8122 | joychud@ucla.edu |
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| ID | Term |
|---|---|
| D019969 | Amphetamine-Related Disorders |
| D015438 | Health Behavior |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| standard | No Intervention | 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. |
| Rancho Cucamonga |
| California |
| 91730 |
| United States |
| BG001 | Continuous Voucher Schedule | Those in the continuous condition will receive a 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. contingency managment voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors. |
| BG002 | Intermittent Unpredictable Schedule | Those in the intermittent unpredictable condition will be eligible to receive a voucher on one day a week. This date will be randomly determined and they will not know in advance what day it will be. Participants in this group will receive a voucher following their first three methamphetamine-negative urine tests. Following that they will 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. 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. contingency managment voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors. |
| BG003 | Standard | Participants assigned to the standard condition will not receive vouchers for the provision of clean urines. |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Continuous Voucher Schedule | Those in the continuous condition will receive a 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. contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors. |
| OG002 | Intermittent Unpredictable Schedule | Those in the intermittent unpredictable condition will be eligible to receive a voucher on one day a week. This date will be randomly determined and they will not know in advance what day it will be. Participants in this group will receive a voucher following their first three methamphetamine-negative urine tests. Following that they will 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. 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. contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors. |
| OG003 | Standard | Participants assigned to the standard condition will not receive vouchers for the provision of clean urines. |
|
|
|
| Primary | Methamphetamine Use, Measured by Number of Consecutive Days of Abstinence | 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 | Posted | Mean | Standard Deviation | days | 16 Weeks |
|
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| Primary | Methamphetamine Use, Follow-Up | Drug use measured by urine toxicology conducted by on site EMIT assay over time | Posted | Number | percentage of negative urine samples | 1x/month for 4 months | Urine samples | Participants |
|
|
|
|
| 5 |
| 119 |
| 1 |
| 119 |
| EG001 | 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. | 3 | 119 | 5 | 119 |
| EG002 | 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. | 1 | 119 | 1 | 119 |
| EG003 | 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. | 1 | 119 | 3 | 119 |
|
| back and lung injury | Injury, poisoning and procedural complications | Systematic Assessment | Ct hospitalized for stab wounds in the face and back. Ct underwent surgery for back and lung injuries. Ct was released with prescriptions for painkillers, iron and glucose. |
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| child birth | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Ct reported seeking medical attention due to labor pains. Ct gave birth to health child. |
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| pneumonia | Infections and infestations | Systematic Assessment | Ct hospitalized for difficulty breathing and edema, diagnosed with pneumonia. Ct was hospitalized and received fluids and antibiotics intravenously along with oxygen and breathing treatments. |
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| chest pain | Cardiac disorders | Systematic Assessment | Ct hospitalized to monitor chest pain and tightness. Prescribed heart and pain medication. |
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| Diabetes Mellitus, Type II | Endocrine disorders | Systematic Assessment | Client sought medical attention due to increased thirst and frequency in urination. Client was hospitalized overnight to monitor glucose levels. Client was diagnosed with Diabetes Mellitus, Type II. |
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| High glucose levels | Endocrine disorders | Systematic Assessment | Client sought medical attention for frequent urination and thirst. Client admitted to hospital for high glucose levels and was given insulin for stabilization. |
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| Pneumonia | Infections and infestations | Systematic Assessment | Client sought medical attention due to pains in chest and difficulty breathing. Client was diagnosed with pneumonia. |
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| breathing difficulty | Endocrine disorders | Systematic Assessment | Client sought medical attention as he was having difficulty breathing hearing properly. Client diagnosed with infection that progressed due to high blood sugar levels. |
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| nerve pain | Nervous system disorders | Systematic Assessment | Client underwent surgery to alleviate compression of the seventh cranial nerve. |
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| lower back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Ct sought medical attention for lower back pain. Ct was diagnosed with pinched sciatic nerve, herniated disc, low back muscle strain, and lumbar muscle strain. |
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| abscesses on legs | Infections and infestations | Systematic Assessment | Ct reported seeking medical attention for abscesses on legs. Ct underwent minor surgery to remove boils, and was released the same day. |
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| rash and blisters | Infections and infestations | Systematic Assessment | Ct sought medical attention for rashes and blisters on both legs, which spread throughout body. Ct prescribed broad-spectrum antibiotics, antivirals, and topical ointments |
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| fever | Infections and infestations | Systematic Assessment | Ct reported receiving medical attention for a high fever. Ct was diagnosed with a kidney infection, prescribed an antibiotic, and released the same day. |
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| decayed teeth | Infections and infestations | Systematic Assessment | Client reported receiving oral surgery for decayed teeth. Ct was released the same day with antibiotics. |
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| pain and swelling | Infections and infestations | Systematic Assessment | Client sought medical attention for pain and swelling in testicular area. Ct was diagnosed with build-up of fluid. Client to schedule procedure for drainage. |
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| eye lesions | Eye disorders | Systematic Assessment | Client sought medical attention for eye lesions. Ct was diagnosed with Herpes of the eyes, and was prescribed antibiotic ointments and antiviral drops. |
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| tooth pain | Infections and infestations | Systematic Assessment | Ct reported seeking medical attention for tooth pain. Ct told to schedule tooth extractions. |
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| leg injury | Injury, poisoning and procedural complications | Systematic Assessment | Ct sought medical attention due to a leg injury as a result of falling while hiking. Ct received 21 stitches in left leg, and was prescribed antibiotics. |
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| broken thumb | Injury, poisoning and procedural complications | Systematic Assessment | Client reported seeking medical attention for broken thumb. Splint was placed on client's thumb |
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| <0.01 |
| No |
| Superiority or Other |
| t-test, 2 sided | <0.01 | No | Superiority or Other |
| t-test, 2 sided | 0.20 | No | Superiority or Other |
| Urine samples |
|
| Generalized estimating equations |
| 0.68 |
| No |
| Superiority or Other |
| We used GEE to investigate change in methamphetamine abstinence (i.e., provision of a negative methamphetamine UA) during the follow-up period. | Generalized estimating equations | 0.20 | No | Superiority or Other |