Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention

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.

Conditions

• Cocaine-Related Disorders

Interventions

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.

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.

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.

DRUG

Placebo

The placebo capsule will be filled with corn starch and riboflavin.

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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-11-18

Primary Completion

2021-09-13

Completion

2021-09-13

Countries

• United States

Study Locations