Long-term Behavior Change - 1

NCT00158197 | Completed Results DMC

• 3 other identifiers: NIDA-17407-1R01DA017407R01-17407-1
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 2

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.

Conditions

Amphetamine-related Disorders

Keywords

Adherence; Amphetamine-Related Disorders; Behavior Therapy; Contingency management; Drug Counseling; health behaviors; methamphetamine; sexual risk behaviors; substance dependence

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

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.

Behavioral: contingency management voucher

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.

Behavioral: contingency management voucher

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.

Behavioral: contingency management voucher

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.

Interventions

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.

continuous voucher schedule; intermittent predictable schedule; intermittent unpredictable schedule

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Friends Research Institute, Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Friends Research Institute

Los Angeles, California, 90025, United States

Location

Friends Research Institute

Rancho Cucamonga, California, 91730, United States

Location

Related Publications (1)

• 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.

  PMID: 23708468 RESULT

MeSH Terms

Conditions

Amphetamine-Related Disorders; Health Behavior; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior

Results Point of Contact

• Title: Joy Chudzynski
• Organization: Friends Research Institute

joychud@ucla.edu

323-333-8122

Study Officials

• John Roll, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: December 1, 2004
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: August 25, 2015
• Results First Posted: July 2, 2014

Record last verified: 2015-08

Locations

US (2)