Clinical trial NCT02896712: Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention
Official title: Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention ("Adaptive Trial")
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Drug addiction is a chronic, devastating, but treatable disorder, for which there exists a growing armamentarium of evidence-based interventions, including pharmacotherapies and psychotherapies. A core principle of drug addiction treatment, however, states that no single treatment is appropriate for everyone; rather, treatments need to be adjusted based on patient characteristics and response in order to be maximally effective. Ideally, clinicians would identify a sequence of interventions that works best across different stages of addiction treatment, from abstinence initiation to relapse prevention. Adaptive treatment interventions have been used successfully to inform this sequential clinical decision-making process. For cocaine use disorders (CUD), the most potent intervention currently available for initiating abstinence is behavior therapy using contingency management (CM) procedures. Intensive CM has been shown to produce initial cocaine abstinence rates of 40%, unmatched by all other forms of behavioral or pharmacological treatment, making it a prototypical first-line therapy for CUD. Importantly, achievement of initial abstinence predicts future abstinence. For the clinician, these research findings translate into a straightforward question: Can the investigators drive CM response rates even higher with targeted adjunctive interventions?

The proposed sequential, multiple assignment, randomized trial (SMART) will provide the data needed to answer this question. First, the investigators will determine whether Acceptance and Commitment Therapy (ACT) in combination with CM increases initial treatment response rates. The investigators hypothesize that four weeks of treatment with ACT+CM will produce higher abstinence rates than initial treatment combining standard Drug Counseling with CM (DC+CM). The hypothesized synergism of ACT+CM on primary treatment mechanisms of experiential avoidance and reward sensitivity, respectively, will be examined. Second, for patients who do not respond to initial treatment, the investigators will examine whether dopamine-targeted pharmacotherapy is an effective augmentation strategy. Specifically, the investigators hypothesize that continued ACT+CM treatment with modafinil augmentation will be most effective in promoting abstinence relative to treatment combinations involving continued DC and/or placebo. Third, for patients who respond to initial treatment, the investigators will assess the relative benefit of continued treatment with ACT+CM, as compared to DC+CM, to prevent relapse. ACT emphasizes goal-directed actions based on values that are intrinsically motivating, and is thereby expected to be a more effective intervention for extending the duration of abstinence following initial treatment with intensive CM.

Eligibility criteria: Inclusion Criteria:

1. be between 18 and 60 years of age
2. meet DSM-5 criteria for current cocaine use disorder of at least moderate severity (≥ 4 symptoms)
3. have at least 1 positive urine BE specimen (≥ 150 ng/mL) during intake
4. be in acceptable health on the basis of interview, medical history and physical exam
5. 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.
6. be able to understand the consent form and provide written informed consent
7. be able to provide the names of at least 2 persons who can generally locate their whereabouts.

Exclusion Criteria:

1. current DSM-5 diagnosis for substance use disorder (of at least moderate severity) other than cocaine, marijuana, or nicotine
2. 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).
3. significant current suicidal or homicidal ideation
4. 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)
5. taking medications that could adversely interact with modafinil (e.g., propranolol, phenytoin, warfarin, diazepam)
6. having conditions of probation or parole requiring reports of drug use to officers of the court
7. impending incarceration
8. pregnant or nursing for female patients
9. inability to read, write, or speak English

Primary outcomes:
measure: Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen
timeFrame: 4 weeks
measure: Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen
timeFrame: 12 Weeks
Secondary outcomes:
measure: Cocaine Use as Indicated by Proportion of Days of no Cocaine Use as Assessed by Timeline Follow-back
timeFrame: 4 weeks
measure: Cocaine Use as Assessed by Proportion of Days of no Cocaine Use as Assessed by Timeline Follow-back
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: UTHealth Center for Neurobehavioral Research on Addiction
state: Texas
Study officials:
References:
citation: Lathan 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.
citation: Webber 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.
citation: Yoon 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.