Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention

Phase 2

Completed

• Conditions: Cocaine-Related Disorders
• Interventions: Behavioral: Acceptance and Commitment Therapy (ACT); Behavioral: Drug Counseling (DC); Behavioral: Contingency Management (CM); Drug: Placebo; Drug: Modafinil

• Registration Number: NCT02896712
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Study Timeline

• Study First Submitted: 2016-09-06
• Study First Submitted QC: 2016-09-06
• Study First Posted: 2016-09-12
• Study Start: 2016-11-18
• Primary Completion: 2021-09-13
• Study Completion: 2021-09-13
• Results First Submitted: 2022-09-13
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-23
• Last Update Submitted: 2023-01-23
• Results First Posted: 2023-02-08
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACT plus CM, with Modafinil	Contingency Management (CM)	Acceptance 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, with Placebo	Contingency Management (CM)	Drug 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	Contingency Management (CM)	Drug Counseling and Contingency Management for cocaine use will be administered and augmented with a Modafinil (300mg) capsule during Phase 2 (weeks 5-12).
ACT plus CM	Contingency Management (CM)	Acceptance 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	Contingency Management (CM)	Acceptance 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).
DC plus CM	Contingency Management (CM)	Drug Counseling and Contingency Management for cocaine use will be administered to help educate patients about important concepts in addiction recovery.
ACT plus CM	Acceptance and Commitment Therapy (ACT)	Acceptance 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	Acceptance and Commitment Therapy (ACT)	Acceptance 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	Acceptance and Commitment Therapy (ACT)	Acceptance 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).
ACT plus CM, with Placebo	Placebo	Acceptance 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).
DC plus CM	Drug Counseling (DC)	Drug Counseling and Contingency Management for cocaine use will be administered to help educate patients about important concepts in addiction recovery.
DC plus CM, with Modafinil	Drug Counseling (DC)	Drug Counseling and Contingency Management for cocaine use will be administered and augmented with a Modafinil (300mg) capsule during Phase 2 (weeks 5-12).
DC plus CM, with Modafinil	Modafinil	Drug Counseling and Contingency Management for cocaine use will be administered and augmented with a Modafinil (300mg) capsule during Phase 2 (weeks 5-12).
DC plus CM, with Placebo	Drug Counseling (DC)	Drug 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 Placebo	Placebo	Drug Counseling and 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	Modafinil	Acceptance 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).

Primary Outcome Measures

Name	Time	Method
Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen	12 Weeks	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.

Secondary Outcome Measures

Name	Time	Method
Cocaine Use as Assessed by Proportion of Days of no Cocaine Use as Assessed by Timeline Follow-back	12 Weeks	Timeline Followback (TLFB) is a method to assess of cocaine use that involves asking study participants to self-report their cocaine use over the past week.
Cocaine Use as Indicated by Proportion of Days of no Cocaine Use as Assessed by Timeline Follow-back	4 weeks	Timeline Followback (TLFB) is a method to assess of cocaine use that involves asking study participants to self-report their cocaine use over the past week.

Trial Locations

Locations (1)

UTHealth Center for Neurobehavioral Research on Addiction; 🇺🇸 Houston, Texas, United States