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Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention

This study is currently recruiting participants.
Verified September 2016 by Joy Schmitz, The University of Texas Health Science Center, Houston
Sponsor:
ClinicalTrials.gov Identifier:
NCT02896712
First Posted: September 12, 2016
Last Update Posted: September 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Joy Schmitz, The University of Texas Health Science Center, Houston
  Purpose

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.


Condition Intervention Phase
Cocaine-Related Disorders Behavioral: Acceptance and Commitment Therapy (ACT) Behavioral: Drug Counseling (DC) Behavioral: Contingency Management (CM) Drug: Placebo Drug: Modafinil Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention ("Adaptive Trial")

Resource links provided by NLM:


Further study details as provided by Joy Schmitz, The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Cocaine Use as assessed by urine drug screen levels [ Time Frame: 12 Weeks ]

Secondary Outcome Measures:
  • Cocaine Use as assessed by Timeline Follow-back [ Time Frame: 12 Weeks ]

Estimated Enrollment: 160
Study Start Date: January 2016
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ACT plus 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.
Behavioral: Acceptance and Commitment Therapy (ACT)
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.
Other Name: ACT
Behavioral: Contingency Management (CM)
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.
Other Name: CM
Active Comparator: ACT plus CM, with 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).
Behavioral: Acceptance and Commitment Therapy (ACT)
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.
Other Name: ACT
Behavioral: Contingency Management (CM)
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.
Other Name: CM
Drug: Placebo
The placebo capsule will be filled with corn starch and riboflavin.
Other Name: Corn Starch
Experimental: ACT plus CM, with 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).
Behavioral: Acceptance and Commitment Therapy (ACT)
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.
Other Name: ACT
Behavioral: Contingency Management (CM)
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.
Other Name: CM
Drug: Modafinil
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.
Other Name: Provigil
Active Comparator: DC plus CM
Drug Counseling and Contingency Management for cocaine use will be administered to help educate patients about important concepts in addiction recovery.
Behavioral: Drug Counseling (DC)
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.
Other Name: DC
Behavioral: Contingency Management (CM)
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.
Other Name: CM
Active Comparator: DC plus CM, with Placebo
Drug Counseling and Contingency Management for cocaine use will be administered and augmented with a placebo capsule during Phase 2 (weeks 5-12).
Behavioral: Drug Counseling (DC)
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.
Other Name: DC
Behavioral: Contingency Management (CM)
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.
Other Name: CM
Drug: Placebo
The placebo capsule will be filled with corn starch and riboflavin.
Other Name: Corn Starch
Experimental: DC plus CM, with 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).
Behavioral: Drug Counseling (DC)
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.
Other Name: DC
Behavioral: Contingency Management (CM)
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.
Other Name: CM
Drug: Modafinil
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.
Other Name: Provigil

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02896712


Contacts
Contact: Joy M Schmitz, PhD 713-486-2867 joy.m.schmitz@uth.tmc.edu
Contact: Jessica N Vincent, BS 713-486-2803 jessica.n.vincent@uth.tmc.edu

Locations
United States, Texas
UTHealth Center for Neurobehavioral Research on Addiction Recruiting
Houston, Texas, United States, 77054
Contact: Joy M Schmitz, PhD    713-486-2867    Joy.M.Schmitz@uth.tmc.edu   
Principal Investigator: Joy M Schmitz, Ph.D.         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
  More Information

Responsible Party: Joy Schmitz, Professor and CNRA Director, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02896712     History of Changes
Other Study ID Numbers: HSC-MS-15-0595
First Submitted: September 6, 2016
First Posted: September 12, 2016
Last Update Posted: September 16, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Cocaine-Related Disorders
Cocaine
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Modafinil
Armodafinil
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers


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