Long-term Behavior Change - 1

Amphetamine-related Disorders Clinical Trial

Official title:

Behavior Change: Reinforcement Schedule Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00158197
• Other study ID #: NIDA-17407-1
• Secondary ID: R01DA017407R01-1
• Status: Completed
• Phase: N/A
• First received: September 8, 2005
• Last updated: August 11, 2015
• Start date: December 2004
• Est. completion date: June 2008

Study information

• Verified date: August 2015
• Source: Friends Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amphetamine-related Disorders

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Friends Research Institute	Los Angeles	California
United States	Friends Research Institute	Rancho Cucamonga	California

Sponsors (2)

Lead Sponsor	Collaborator
Friends Research Institute, Inc.	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
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	16 Weeks	No
Primary	Methamphetamine Use, Follow-Up	Drug use measured by urine toxicology conducted by on site EMIT assay over time	1x/month for 4 months	No