Extending Long-term Outcomes Through an Adaptive Aftercare Intervention

• Sponsor: UConn Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT02143063
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 274
• Locations: 4
• Arms: 3
• Actual Duration (Months): 74
• Patients Per Site: 68.5
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

Reinforcement interventions have pronounced effects on reducing cocaine use. This study will evaluate a novel approach in which reinforcement frequency varies by patient performance. To test efficacy, 280 patients with cocaine use disorder will be randomly assigned to: standard care, standard care plus traditional twice weekly reinforcement, or standard care plus adaptive variable interval reinforcement.

Condition or Disease	Intervention/Treatment	Phase
Cocaine Use Disorder; Contingency Management	Behavioral: prize contingency management on a traditional twice weekly schedule for cocaine abstinence; Behavioral: prize contingency management on a variable interval schedule for cocaine abstinence; Behavioral: standard care	N/A

Detailed Description

Reinforcement interventions have pronounced effects on reducing cocaine use. We developed and evaluated a low-cost reinforcement intervention, systematically moving it through the Stages of development to dissemination and broad clinical implementation. In an ongoing project, reinforcement interventions are yielding benefits when reinforcers are provided at treatment initiation and for longer durations. However, less than half of patients remain engaged for 12 weeks with traditional reinforcement interventions, which require frequent attendance for monitoring and reinforcing abstinence. Interventions that extend into aftercare and that are acceptable to and efficacious in preventing long-term relapse are critically needed.

Reinforcement interventions are efficacious during periods they are in effect, and pilot data show that variable interval (VI) reinforcement schedules, once behavior change occurs, hold potential for maintaining gains when administered infrequently. Assessing methods to extend benefits of these interventions is of paramount scientific and clinical concern. This study will evaluate a novel approach in which reinforcement frequency varies by patient performance. In this intervention, reinforcement will be available for 24 weeks, on a progressive VI schedule, that adapts according to patient status. Patients who maintain abstinence earn maximum reinforcers as infrequently as every three weeks on average, while frequency of monitoring and reinforcing abstinence will increase in those who relapse until abstinence is re-instated.

To test efficacy, 280 patients with cocaine use disorder will be randomly assigned to:

standard care (SC), SC+traditional twice weekly reinforcement, or SC+adaptive VI reinforcement. Evaluations will be completed at baseline and throughout 18 months to assess objective and self-reported indices of drug use, psychosocial problems, and HIV risk behaviors. Primary hypotheses are (1) the adaptive VI reinforcement intervention will improve outcomes relative to standard care during the treatment period and throughout follow-up, and (2) the adaptive VI reinforcement intervention will improve outcomes relative to the traditional reinforcement system. This study will also evaluate the roles of cognitive control and treatment outcome. Patients with better cognitive control are expected to maintain longer durations of abstinence across conditions. If these measures differentially relate to outcomes across treatments, such results suggest the potential of pairing reinforcement interventions to individuals most likely to benefit from them; they may also indicate possible markers of response in a treatment-specific manner. If cognitive indices mediate treatment response, future studies can refine interventions to improve cognitive processes and long-term outcomes.

Study Design

• Study Type: Interventional
• Actual Enrollment: 274 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Extending Long-term Outcomes Through an Adaptive Aftercare Intervention
• Actual Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Oct 1, 2020
• Actual Study Completion Date: Oct 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: standard care standard care	Behavioral: standard care
Active Comparator: standard care plus traditional contingency managment prize contingency management on a traditional twice weekly schedule for cocaine abstinence	Behavioral: prize contingency management on a traditional twice weekly schedule for cocaine abstinence; Behavioral: standard care
Experimental: standard care plus variable interval contingency management prize contingency management on a variable interval schedule for cocaine abstinence	Behavioral: prize contingency management on a variable interval schedule for cocaine abstinence; Behavioral: standard care

Outcome Measures

Primary Outcome Measures

1. Longest Duration of Abstinence From Cocaine [baseline through 6 months]

   Longest duration of consecutive cocaine-negative urine toxicology tests

Secondary Outcome Measures

1. Longest Duration of Abstinence From All Substances Tested [baseline through 6 months]

   Based on breath and urine toxicology tests (alcohol, methamphetamine, cocaine, opioids, THC, amphetamine, benzodiazepines)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• be age 18 years or older

• have a cocaine use disorder diagnosis

• be willing to sign informed consent and able to pass an informed consent quiz

Exclusion Criteria:

• serious, uncontrolled psychiatric illness

• in recovery from pathological gambling

• do not speak English

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Regional Network of Programs, Inc.	Bridgeport	Connecticut	United States	06610
2	Alcohol and Drug Recovery Centers, Inc.	Hartford	Connecticut	United States	06112
3	The Hospital of Central Connecticut at New Britain General	New Britain	Connecticut	United States	06050
4	Behavioral Health Network, Inc.	Springfield	Massachusetts	United States	01104

Sponsors and Collaborators

• UConn Health
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Nancy Petry, Ph.D., UConn Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 31, 2020
• Informed Consent Form - Nov 19, 2018

More Information

Publications

None provided.

• Responsible Party: Sheila Alessi, Associate Professor, UConn Health
• ClinicalTrials.gov Identifier: NCT02143063
• Other Study ID Numbers: 14-090H-2; P50DA009241
• First Posted: May 20, 2014
• Last Update Posted: Jan 13, 2022
• Last Verified: Jan 1, 2022

• Additional relevant MeSH terms: Cocaine

Study Results

Participant Flow

Arm/Group Title	Standard Care (SC)	Standard Care Plus Traditional Contingency Management	Standard Care Plus Variable Interval Contingency Management
Arm/Group Description	Standard care IOP treatment for cocaine use disorder. In addition, SC participants submitted urine samples during the 24-week intervention phase. Patients selected two days a week on which drug screens might occur (e.g., M/Th, T/F). On the morning of each potential drug screen day, research staff texted participants to indicate if a sample was due. In weeks 1-3, urine screens occurred on two days per week. In weeks 4-9, screens occurred on one randomly selected day each week. In weeks 10-24, drug screens occurred once every 2-3 weeks on average. After a missed sample, the next two screen days were prompted for sample submission. An algorithm developed in-house was used to generate and monitor the drug screen schedule. Participants received $2 per requested sample submitted plus a $20 bonus for submitting all requested samples in a 4-week period. The goal was to result in 18 samples on average, equivalent relative to the new SC plus variable interval CM condition.	Standard care plus "standard" prize contingency management twice weekly for urine screens indicating cocaine abstinence. Urine screens occurred on the same monitoring schedule described for the SC condition, including $2 per requested sample submitted and a $20 bonus for all requested samples in a 4-week period. In addition, participants received chances for prizes on a escalating reinforcement schedule and with a reset condition for unexcused missed samples. Mean maximum earnings for cocaine-negative urine screens was $460 in prizes.	Standard care plus prize contingency management on a variable interval schedule for cocaine abstinence. Relative to the traditional CM condition, in this condition, the frequency of samples to earn reinforcement decreased over time contingent on achieving periods of sustained abstinence. The schedule was designed to result in an average of at least 18 urine samples over 24 weeks among participants maintaining abstinence. Participants received the sample compensation for submitted urine samples regardless of results as in the other two conditions.
Period Title: Overall Study
STARTED	61	105	108
COMPLETED	45	75	78
NOT COMPLETED	16	30	30

Baseline Characteristics

Arm/Group Title	Standard Care	Standard Care Plus Traditional Contingency Managment	Standard Care Plus Variable Interval Contingency Management	Total
Arm/Group Description	standard care standard care	prize contingency management on a traditional twice weekly schedule for cocaine abstinence prize contingency management on a traditional twice weekly schedule for cocaine abstinence standard care	prize contingency management on a variable interval schedule for cocaine abstinence prize contingency management on a variable interval schedule for cocaine abstinence standard care	Total of all reporting groups
Overall Participants	61	105	108	274
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.9 (9.2)	40.7 (9.6)	39.7 (10.1)	40.1 (9.7)
Sex: Female, Male (Count of Participants)
Female	32 52.5%	57 54.3%	58 53.7%	147 53.6%
Male	29 47.5%	48 45.7%	50 46.3%	127 46.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	14 23%	23 21.9%	27 25%	64 23.4%
Not Hispanic or Latino	47 77%	81 77.1%	81 75%	209 76.3%
Unknown or Not Reported	0 0%	1 1%	0 0%	1 0.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1.6%	2 1.9%	0 0%	3 1.1%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	16 26.2%	35 33.3%	30 27.8%	81 29.6%
White	33 54.1%	52 49.5%	64 59.3%	149 54.4%
More than one race	5 8.2%	4 3.8%	6 5.6%	15 5.5%
Unknown or Not Reported	6 9.8%	12 11.4%	8 7.4%	26 9.5%
Region of Enrollment (participants) [Number]
United States	61 100%	105 100%	108 100%	274 100%

Outcome Measures

1. Primary Outcome

Title	Longest Duration of Abstinence From Cocaine
Description	Longest duration of consecutive cocaine-negative urine toxicology tests
Time Frame	baseline through 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Standard Care Plus Traditional Contingency Managment	Standard Care Plus Variable Interval Contingency Management
Arm/Group Description	standard care standard care	prize contingency management on a traditional twice weekly schedule for cocaine abstinence prize contingency management on a traditional twice weekly schedule for cocaine abstinence standard care	prize contingency management on a variable interval schedule for cocaine abstinence prize contingency management on a variable interval schedule for cocaine abstinence standard care
Measure Participants	58	104	104
Median (Inter-Quartile Range) [weeks]	4.14	6.64	6.93

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care, Standard Care Plus Variable Interval Contingency Management
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.01
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	comparison of rank sum
	Estimated Value	3752.0
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Standard Care Plus Traditional Contingency Managment, Standard Care Plus Variable Interval Contingency Management
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.78
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	comparison of rank sum
	Estimated Value	5287.5
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Longest Duration of Abstinence From All Substances Tested
Description	Based on breath and urine toxicology tests (alcohol, methamphetamine, cocaine, opioids, THC, amphetamine, benzodiazepines)
Time Frame	baseline through 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Standard Care Plus Traditional Contingency Managment	Standard Care Plus Variable Interval Contingency Management
Arm/Group Description	standard care standard care	prize contingency management on a traditional twice weekly schedule for cocaine abstinence prize contingency management on a traditional twice weekly schedule for cocaine abstinence standard care	prize contingency management on a variable interval schedule for cocaine abstinence prize contingency management on a variable interval schedule for cocaine abstinence standard care
Measure Participants	58	104	104
Median (Inter-Quartile Range) [weeks]	4.75	5.93	5.71

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard Care, Standard Care Plus Traditional Contingency Managment
	Comments	Primary Aim 1: Compare the standard care and standard care plus traditional CM conditions
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.02
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	comparison of rank sum
	Estimated Value	3675.5
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Standard Care Plus Traditional Contingency Managment, Standard Care Plus Variable Interval Contingency Management
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.61
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	comparison of rank sum
	Estimated Value	5189.5
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	18 months
Arm/Group Title	Standard Care		Standard Care Plus Traditional Contingency Managment		Standard Care Plus Variable Interval Contingency Management
Arm/Group Description	standard care standard care		prize contingency management on a traditional twice weekly schedule for cocaine abstinence prize contingency management on a traditional twice weekly schedule for cocaine abstinence standard care		prize contingency management on a variable interval schedule for cocaine abstinence prize contingency management on a variable interval schedule for cocaine abstinence standard care
All Cause Mortality
	Standard Care		Standard Care Plus Traditional Contingency Managment		Standard Care Plus Variable Interval Contingency Management
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/61 (0%)		1/105 (1%)		1/108 (0.9%)
Serious Adverse Events
	Standard Care		Standard Care Plus Traditional Contingency Managment		Standard Care Plus Variable Interval Contingency Management
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	46/61 (75.4%)		66/105 (62.9%)		77/108 (71.3%)
General disorders
Inpatient medical treatment	12/61 (19.7%)	19	20/105 (19%)	28	18/108 (16.7%)	25
Death	0/61 (0%)	0	1/105 (1%)	1	1/108 (0.9%)	1
Psychiatric disorders
Inpatient psychiatric treatment	9/61 (14.8%)	18	5/105 (4.8%)	7	12/108 (11.1%)	16
Social circumstances
Inpatient substance use treatment	27/61 (44.3%)	58	40/105 (38.1%)	59	47/108 (43.5%)	66
Other (Not Including Serious) Adverse Events
	Standard Care		Standard Care Plus Traditional Contingency Managment		Standard Care Plus Variable Interval Contingency Management
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/61 (19.7%)		7/105 (6.7%)		9/108 (8.3%)
General disorders
ER visit for overdose	3/61 (4.9%)	3	3/105 (2.9%)	5	3/108 (2.8%)	3
Psychiatric disorders
Suicidal Ideation	9/61 (14.8%)	11	4/105 (3.8%)	5	6/108 (5.6%)	6

Limitations/Caveats

Analyses presented assessed outcomes at the group-level and using main a priori analytic methods. Additional analyses should assess outcomes in the context of potential baseline predictors, assess for patterns in individual-level trajectories over time and by group, and incorporate additional advanced analytic techniques.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.