Phase 2 N=118 Randomized Quadruple-blind Treatment

Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention

Cocaine-Related Disorders

Bottom Line

View on ClinicalTrials.gov: NCT02896712 ↗

Enrolled (actual)

118

Serious AEs

3.6%

Results posted

Feb 2023

Primary outcome: Primary: Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen — 0.31; 0.24 proportion of visits

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Acceptance and Commitment Therapy (ACT) (Behavioral); Drug Counseling (DC) (Behavioral); Contingency Management (CM) (Behavioral); Placebo (Drug); Modafinil (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center, Houston
Primary completion: Sep 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen	0.67; 0.22; 0.12; 0.70; 0.12; 0.10	—
PRIMARY Cocaine Use as Assessed by Proportion of Visits (Excluding Excused Absences) With Cocaine-negative Urine Drug Screen	0.67; 0.22; 0.12; 0.70; 0.12; 0.10	—
SECONDARY Cocaine Use as Indicated by Proportion of Days of no Cocaine Use as Assessed by Timeline Follow-back	0.70; 0.66	—
SECONDARY Cocaine Use as Assessed by Proportion of Days of no Cocaine Use as Assessed by Timeline Follow-back	0.83; 0.58; 0.70; 0.88; 0.63; 0.64	—

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.

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02896712). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.