Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention

• Status: Completed
• Trial end date: 2021-09-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Treatments: Armodafinil; Cocaine; Modafinil

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