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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05585203
Other study ID # IRB-21-08-3875
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date September 20, 2024

Study information

Verified date March 2024
Source Wayne State University
Contact David Ledgerwood, PhD
Phone 313-993-1380
Email dledgerw@med.wayne.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, the investigators will implement contingency management at rural recovery houses, where individuals with substance use disorders reside. Contingency management is a behavioral intervention in which participants receive incentives (rewards) when they complete planned tasks that are consistent with their recovery efforts. House staff members will also participate in this study and will be trained to provide contingency management to residents. The investigators will compare recovery houses that implement contingency management to matched houses that do not, and the main outcomes will be engagement in the planned activities and retention in the recovery houses. Participants will receive contingency management for up to 12 weeks and follow-up will occur 6 months post-treatment.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date September 20, 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age 18 or older; 2. a resident of the recovery house; and 3. able to provide informed consent. Exclusion Criteria: 1. expected to be discharged from the recovery house in the next two months; 2. experiencing uncontrolled mania, psychosis or suicidality.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Contingency management
The investigators will implement a prize-based contingency management protocol in which residents will complete three pre-planned recovery-oriented activities each week for a period of up to 12 weeks. Upon verified completion of the activities each week, participants may earn prize incentives through drawing from a prize fishbowl or spinning a virtual prize wheel. Prizes will be money added to a debit card. On the first week and individual has completed pre-planned activities, s/he can receive up to 1 draw per activity completed (3 total), and each week the number of prize draws per activity will escalate by 1. If a participant fails to complete any activities, he/she will not receive the draws for the uncompleted activities, and the prize draws would be reset to 1 in the next week. Participants can earn up to $75 in incentives in total.
Usual Care
Participants in this arm will receive usual care that they would normally receive at the recovery houses. Recovery residences vary considerably, this form of housing benefits individuals in recovery by reinforcing a substance-free lifestyle and providing direct connections to other peers in recovery, mutual support groups and recovery support services.

Locations

Country Name City State
United States Wayne State University School of Medicine Detroit Michigan

Sponsors (1)

Lead Sponsor Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

References & Publications (12)

Frisch, M.B., Cornell, J., Villanueva, M. & Retzlaff, P.J. (1992). Clinical validation of the quality of life inventory: A measure of life satisfaction for treatment planning and outcome assessment. Psychological Assessment, 4, 92-101.

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x. — View Citation

Novy, D.M., Nelson, D.V., Goodwin, J. & Rowzee, R.D. (1993). Psychometric comparability of the State-Trait Anxiety Inventory for different ethnic subpopulations. Psychological Assessment, 5, 343-349.

Petry NM, Alessi SM, Ledgerwood DM, Sierra S. Psychometric properties of the contingency management competence scale. Drug Alcohol Depend. 2010 Jun 1;109(1-3):167-74. doi: 10.1016/j.drugalcdep.2009.12.027. Epub 2010 Feb 11. — View Citation

Petry NM, Alessi SM, Ledgerwood DM. A randomized trial of contingency management delivered by community therapists. J Consult Clin Psychol. 2012 Apr;80(2):286-98. doi: 10.1037/a0026826. Epub 2012 Jan 16. — View Citation

Petry NM, Alessi SM, Ledgerwood DM. Contingency management delivered by community therapists in outpatient settings. Drug Alcohol Depend. 2012 Apr 1;122(1-2):86-92. doi: 10.1016/j.drugalcdep.2011.09.015. Epub 2011 Oct 5. — View Citation

Petry NM, Martin B, Finocche C. Contingency management in group treatment: a demonstration project in an HIV drop-in center. J Subst Abuse Treat. 2001 Sep;21(2):89-96. doi: 10.1016/s0740-5472(01)00184-2. — View Citation

Rash CJ, Petry NM, Kirby KC, Martino S, Roll J, Stitzer ML. Identifying provider beliefs related to contingency management adoption using the contingency management beliefs questionnaire. Drug Alcohol Depend. 2012 Mar 1;121(3):205-12. doi: 10.1016/j.drugalcdep.2011.08.027. Epub 2011 Sep 16. — View Citation

Shapiro, S.S. & Wilk, M.B. (1965). An analysis of variance test for normality (complete samples). Biometrika, 52.3/4, 591-611.

Sobell, L.C., & Sobell, M.B. (1992). Timeline follow-back: A technique for assessing self-reported alcohol consumption. In R.Z. Litten and J.P. Allen (eds.), Measuring alcohol consumption: Psychosocial and biochemical methods (pp. 41-72). Totowa, NJ: Humana Press.

Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83. — View Citation

Yi R, Johnson MW, Giordano LA, Landes RD, Badger GJ, Bickel WK. THE EFFECTS OF REDUCED CIGARETTE SMOKING ON DISCOUNTING FUTURE REWARDS: AN INITIAL EVALUATION. Psychol Rec. 2008 Spring;58(2):163-174. doi: 10.1007/BF03395609. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment retention Length of time (in days) a resident resides in the recovery house Time until leaving the recovery home from study baseline up to one year
Primary Engagement in recovery-oriented activities Participants will engage in up to 3 planned recovery activities (noted on a tracking form) up to 12 week treatment
Secondary Treatment Satisfaction Treatment Satisfaction Questionnaire (Scores range from 1 to 7 with higher scores reflecting greater satisfaction) Post-treatment (Week 12)
Secondary Quality of Life Assessment Self-report Quality of Life inventory (scores range from -3 to 3 with higher scores reflecting greater quality of life) Baseline, post-treatment (week 12) and 6-month follow up
Secondary Self-Reported Health Short Form 36 (SF-36) is a brief measure of overall self-reported health. Scores range from 0 (maximum disability) to 100 (no disability) Baseline, post-treatment (week 12) and 6-month follow up
Secondary Patient Health Questionnaire - 9 A measure of depression symptoms. Scores on the PHQ 9 range from 0 (no depression) to 27 (severe depression). Baseline, post-treatment (week 12) and 6-month follow up
Secondary Substance Use Urine drug screen of metabolites for cocaine, methamphetamine, barbiturates, opioids, cannabis, alcohol and benzodiazepines Baseline, weekly for 12 weeks, post-treatment (week 12) and 6-month follow up
Secondary Timeline Follow-back for substance use Timeline Follow-back (TLFB) is a self-report, calendar-based measure of the frequency of substance use Baseline, weekly for 12 weeks, post-treatment (week 12) and 6-month follow up
Secondary Treatment Feasibility Treatment Feasibility will assessed as the proportion of eligible participants who are willing to participate after initial screening. Baseline
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