Clinical trial
Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention ("Adaptive Trial")
Name
HSC-MS-15-0595
Description
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 arms
Trial start
2016-11-18
Estimated PCD
2021-09-13
Trial end
2021-09-13
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
ACT plus CM, ACT plus CM, with Modafinil, ACT plus CM, with Placebo
Other names:
ACT
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.
Arms:
DC plus CM, DC plus CM, with Modafinil, DC plus CM, with Placebo
Other names:
DC
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.
Arms:
ACT plus CM, ACT plus CM, with Modafinil, ACT plus CM, with Placebo, DC plus CM, DC plus CM, with Modafinil, DC plus CM, with Placebo
Other names:
CM
Placebo
The placebo capsule will be filled with corn starch and riboflavin.
Arms:
ACT plus CM, with Placebo, DC plus CM, with Placebo
Other names:
Corn Starch
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.
Arms:
ACT plus CM, with Modafinil, DC plus CM, with Modafinil
Other names:
Provigil
Size
118
Primary endpoint
Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen
4 weeks
Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen
12 Weeks
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 118, 'type': 'ACTUAL'}}
Updated at
2023-02-08
1 organization
1 product
1 drug
1 indication
Drug
VarlilumabIndication
Cocaine-Related DisordersProduct
Modafinil