Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention
1 other identifier
interventional
118
1 country
1
Brief Summary
First, the investigators will determine whether Acceptance and Commitment Therapy in combination with Contingency Management increases initial treatment response rates. Second, for patients who do not respond to initial treatment, the investigators will examine whether dopamine-targeted pharmacotherapy is an effective augmentation strategy. Third, for patients who respond to initial treatment, the investigators will assess the relative benefit of continued treatment with Acceptance and Commitment Therapy in combination with Contingency Management, as compared to Drug Counseling in combination with Contingency Management, to prevent relapse.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2016
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2016
CompletedFirst Posted
Study publicly available on registry
September 12, 2016
CompletedStudy Start
First participant enrolled
November 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2021
CompletedResults Posted
Study results publicly available
February 8, 2023
CompletedFebruary 8, 2023
January 1, 2023
4.8 years
September 6, 2016
September 13, 2022
January 23, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen
Urine is assessed for levels of the cocaine metabolite benzoylecgonine (BE), and the drug screen is considered positive for cocaine use if BE level is ≥ 150 ng/mL.
4 weeks
Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen
Urine is assessed for levels of the cocaine metabolite benzoylecgonine (BE), and the drug screen is considered positive for cocaine use if BE level is ≥ 150 ng/mL.
12 Weeks
Secondary Outcomes (2)
Cocaine Use as Indicated by Proportion of Days of no Cocaine Use as Assessed by Timeline Follow-back
4 weeks
Cocaine Use as Assessed by Proportion of Days of no Cocaine Use as Assessed by Timeline Follow-back
12 Weeks
Study Arms (6)
ACT plus CM
ACTIVE COMPARATORAcceptance and Commitment Therapy along with Contingency Management for cocaine use will be administered to help decrease experiential avoidance while increasing acceptance and willingness to experience unpleasant thoughts, feelings, and physical symptoms.
ACT plus CM, with Placebo
ACTIVE COMPARATORAcceptance and Commitment Therapy along with Contingency Management for cocaine use will be administered and augmented with a placebo capsule during Phase 2 (weeks 5-12).
ACT plus CM, with Modafinil
EXPERIMENTALAcceptance and Commitment Therapy along with Contingency Management for cocaine use will be administered and augmented with a Modafinil (300mg) capsule during Phase 2 (weeks 5-12).
DC plus CM
ACTIVE COMPARATORDrug Counseling and Contingency Management for cocaine use will be administered to help educate patients about important concepts in addiction recovery.
DC plus CM, with Placebo
ACTIVE COMPARATORDrug Counseling and Contingency Management for cocaine use will be administered and augmented with a placebo capsule during Phase 2 (weeks 5-12).
DC plus CM, with Modafinil
EXPERIMENTALDrug Counseling and Contingency Management for cocaine use will be administered and augmented with a Modafinil (300mg) capsule during Phase 2 (weeks 5-12).
Interventions
ACT will assist cocaine patients to notice internal cravings and triggers, abandon attempts to manage these triggers via active avoidance, suppression or other control-based strategies, and to make commitments to engage in behaviors consistent with chosen values or goals. ACT encourages clients to experience thoughts and feelings from an observer perspective, and helps clients not to believe distressing thoughts and feelings as if those thoughts and feelings are literally true and in need of action. ACT treatment will be based on the ACT therapy manual developed and tested previously.
The investigators will use the manual-guided individual DC modeled after the NIDA Collaborative Cocaine Treatment Study and used as the active control therapy in previous studies. DC approximates clinical practice as it is considered the most common type of evidence-based treatment in the community for patients actively using cocaine.
The investigators will use the same high-magnitude CM schedule shown previously to be feasible and effective in facilitating initial cocaine abstinence. Subjects will earn vouchers for cocaine-negative urine samples collected at scheduled clinic visits each week. Under an escalating reinforcement schedule, voucher values will begin at $15 and increase by $10 for each consecutive negative urine. Bonus vouchers of $10 will be given for three consecutive negative urines. Provision of a cocaine-positive urine or failure to provide a scheduled sample will result in no vouchers earned and will reset the schedule to the initial value of $15.
The placebo capsule will be filled with corn starch and riboflavin.
Modafinil capsules will start at 200 mg (day 1) and increase to the fixed dose of 300 mg (day 2) and will also contain riboflavin.
Eligibility Criteria
You may qualify if:
- be between 18 and 60 years of age
- meet DSM-5 criteria for current cocaine use disorder of at least moderate severity (≥ 4 symptoms)
- have at least 1 positive urine BE specimen (≥ 150 ng/mL) during intake
- be in acceptable health on the basis of interview, medical history and physical exam
- agree to use an acceptable method of birth control during study participation and for one month after discontinuation of the study medication. Non-hormonal methods of contraception are recommended, including barrier contraceptives (e.g., diaphragm, cervical cap, male condom) or intrauterine device (IUD). Steroid contraceptives if used with non-hormonal methods are acceptable.
- be able to understand the consent form and provide written informed consent
- be able to provide the names of at least 2 persons who can generally locate their whereabouts.
You may not qualify if:
- current DSM-5 diagnosis for substance use disorder (of at least moderate severity) other than cocaine, marijuana, or nicotine
- have a DSM-5 axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe (e.g., psychosis, dementia).
- significant current suicidal or homicidal ideation
- medical conditions contraindicating modafinil pharmacotherapy (e.g., major cardiovascular disease, severe liver disease based on Child-Pugh score of B or C, serious kidney problems)
- taking medications that could adversely interact with modafinil (e.g., propranolol, phenytoin, warfarin, diazepam)
- having conditions of probation or parole requiring reports of drug use to officers of the court
- impending incarceration
- pregnant or nursing for female patients
- inability to read, write, or speak English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UTHealth Center for Neurobehavioral Research on Addiction
Houston, Texas, 77054, United States
Related Publications (6)
de Dios C, Webber HE, Wardle MC, Yoon JH, Patriquin MA, Vincent JN, Schmitz JM, Lane SD. Anti-saccade error rates are associated with somatic depressive symptoms in cocaine use disorder. J Psychopharmacol. 2025 Dec 26:2698811251399579. doi: 10.1177/02698811251399579. Online ahead of print.
PMID: 41451557DERIVEDNunez C, Yoon JH, de Dios C, Dang V, Lane SD, Vincent JN, Schmitz JM, Wardle MC. Undervaluing nondrug rewards or overvaluing cocaine? Cocaine demand relates to cocaine use severity more strongly than anhedonia in individuals with cocaine use disorder. Exp Clin Psychopharmacol. 2025 Feb;33(1):91-99. doi: 10.1037/pha0000744. Epub 2024 Aug 29.
PMID: 39207396DERIVEDWebber HE, Yoon JH, de Dios C, Suchting R, Dang V, Versace F, Green CE, Wardle MC, Lane SD, Schmitz JM. Assessing cocaine motivational value: Comparison of brain reactivity bias toward cocaine cues and cocaine demand. Exp Clin Psychopharmacol. 2023 Aug;31(4):861-867. doi: 10.1037/pha0000622. Epub 2022 Dec 8.
PMID: 36480395DERIVEDLathan EC, Hong JH, Heads AM, Borgogna NC, Schmitz JM. Prevalence and Correlates of Sex Selling and Sex Purchasing among Adults Seeking Treatment for Cocaine Use Disorder. Subst Use Misuse. 2021;56(14):2229-2241. doi: 10.1080/10826084.2021.1981391. Epub 2021 Sep 24.
PMID: 34559026DERIVEDWebber HE, de Dios C, Wardle MC, Suchting R, Green CE, Schmitz JM, Lane SD, Versace F. Electrophysiological responses to emotional and cocaine cues reveal individual neuroaffective profiles in cocaine users. Exp Clin Psychopharmacol. 2022 Oct;30(5):514-524. doi: 10.1037/pha0000450. Epub 2021 Feb 25.
PMID: 33630644DERIVEDYoon JH, Suchting R, McKay SA, San Miguel GG, Vujanovic AA, Stotts AL, Lane SD, Vincent JN, Weaver MF, Lin A, Schmitz JM. Baseline cocaine demand predicts contingency management treatment outcomes for cocaine-use disorder. Psychol Addict Behav. 2020 Feb;34(1):164-174. doi: 10.1037/adb0000475. Epub 2019 Jun 24.
PMID: 31233323DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Joy Schmitz, PhD
- Organization
- The University of Texas Health Science Center at Houston
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and CNRA Director
Study Record Dates
First Submitted
September 6, 2016
First Posted
September 12, 2016
Study Start
November 18, 2016
Primary Completion
September 13, 2021
Study Completion
September 13, 2021
Last Updated
February 8, 2023
Results First Posted
February 8, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share