Cue exposure therapy for treatment of stimulant (methamphetamine) use disorder: study protocol for a randomized controlled trial

ABSTRACT

Background: Cue exposure therapy (CET) is a behavioral approach for treating substance use disorder that due to lack of evidence, its efficacy has been matter of debate over the past two decades. We designed a randomized controlled trial (RCT) to investigate efficacy of adding CET to treatment as usual (TAU) as compare to TAU for stimulants (methamphetamine) use disorder.

Methods: In this RCT, 40 patients with MA use disorder (MUD) who receive treatment from an outpatient clinic are randomly assigned to intervention (CET+TAU) or control (TAU) groups. The CET consisted of 10 weekly individual sessions providing exposure to MA-related cues. The TAU consisted of biweekly individual sessions of cognitive and behavioral treatment that aimed to help patients achieve initial abstinence and relapse prevention. The primary outcome of the study is percent of weekly negative urine tests. Secondary outcomes include severity of addiction, craving, depression, anxiety, stress, self-efficacy, and quality of life.

Conclusion: There is no controlled data determining the CET efficacy of MUD treatment. The issues around development of CET for people with MUD and design of the study have been discussed in this study protocol.

KEYWORDS:

• Methamphetamine use disorder
• cue exposure therapy
• study protocol

Acknowledgments

Authors would like to thank staff of Iranian National Center for Addiction Studies (INCAS) academic clinic.

Authors’ contribution

MT is the principal investigator of the study. MT and AN conceptualized the manuscript and drafted the manuscript. FFL conceptualized the statistical procedures for the study. PB and FFL provide a critical review of the manuscript. All authors read and approved the final manuscript.

Availability of data and material

This is a study protocol for a RCT. After completion of the study, data will be available upon request to the corresponding author.

Ethical approval

This study received approval by the Ethic Committee, Vice-Chancellor for Research, Iran University of Medical Sciences (IR.IUMS.REC 1396.9221521204). Participants are required to provide an informed written consent before entering the study. They could withdraw from the study any time during the study, without any negative effect on receiving TAU in the clinic.

Additional information

Funding

This work was supported by the School of Behavioral Sciences and Mental Health, Iran University of Medical Sciences.