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Long-term Behavior Change - 1

Primary Purpose

Amphetamine-related Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
contingency management voucher
Sponsored by
Friends Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amphetamine-related Disorders focused on measuring Adherence, Amphetamine-Related Disorders, Behavior Therapy, Contingency management, Drug Counseling, health behaviors, methamphetamine, sexual risk behaviors, substance dependence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Friends Research Institute
  • Friends Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

continuous voucher schedule

intermittent predictable schedule

intermittent unpredictable schedule

standard

Arm Description

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.

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.

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 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.

Outcomes

Primary Outcome Measures

Methamphetamine Use During Intervention
Drug use measured by urine toxicology conducted by on site Enzyme-multiplied immunoassay technique (EMIT) assay over time.
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
Methamphetamine Use, Follow-Up
Drug use measured by urine toxicology conducted by on site EMIT assay over time

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
August 11, 2015
Sponsor
Friends Research Institute, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00158197
Brief Title
Long-term Behavior Change - 1
Official Title
Behavior Change: Reinforcement Schedule Effects
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Friends Research Institute, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amphetamine-related Disorders
Keywords
Adherence, Amphetamine-Related Disorders, Behavior Therapy, Contingency management, Drug Counseling, health behaviors, methamphetamine, sexual risk behaviors, substance dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
continuous voucher schedule
Arm Type
Experimental
Arm Description
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.
Arm Title
intermittent predictable schedule
Arm Type
Experimental
Arm Description
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.
Arm Title
intermittent unpredictable schedule
Arm Type
Experimental
Arm Description
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.
Arm Title
standard
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
contingency management voucher
Intervention Description
participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors.
Primary Outcome Measure Information:
Title
Methamphetamine Use During Intervention
Description
Drug use measured by urine toxicology conducted by on site Enzyme-multiplied immunoassay technique (EMIT) assay over time.
Time Frame
3x/week for 16 weeks
Title
Methamphetamine Use, Measured by Number of Consecutive Days of Abstinence
Description
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
Time Frame
16 Weeks
Title
Methamphetamine Use, Follow-Up
Description
Drug use measured by urine toxicology conducted by on site EMIT assay over time
Time Frame
1x/month for 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Roll, Ph.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friends Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Friends Research Institute
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23708468
Citation
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.
Results Reference
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Long-term Behavior Change - 1

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