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Cocaine DependencePhase 1/2NCT00838981

Pharmacotherapy & CM for Opioid and Cocaine Dependence

A Phase 1/2 study testing Modafinil, Sugar Pill and Contingency Management in people with Cocaine Dependence, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare the efficacy of the combined treatment modafinil + Contingency Management (CM) to either treatment condition alone or to yoked-controls on cocaine abstinence. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Cocaine Dependence
What is being tested?
Modafinil, Sugar Pill and Contingency Management
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
91 participants
Where
1 siteUnited States
Study dates
May 2008to Mar 2014
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female opioid-dependent patients between the ages of 18-65 will be entered into the study. Females must not be pregnant as determined by pregnancy screening, nor breast feeding, and must be using acceptable birth control methods during study participation.
  • Current opioid dependence as evidenced by documentation of prior treatment for opioid dependence or signs of withdrawal, self-reported history of opioid dependence for consecutive 12 month period and a positive urine for opiates.
  • Subjects must fulfill DSM-IV criteria for opioid and cocaine dependence.
  • Subjects must have a history of cocaine use, with a reported street cocaine use of a minimum of 1/2 gram during the preceding 30 days. Additionally, laboratory confirmation of recent cocaine use (positive urine for cocaine) within 2 weeks prior to admission to the study is required.
  • Subjects must be treatment-seekers for opioid and cocaine use.

Who cannot join

  • Current DSM-IV diagnosis of other drug or alcohol dependence (other than opiates, cocaine, or tobacco)
  • History of heart disease, left ventricular hypertrophy, ischemic ECG changes, chest pain, arrhythmia, hypertension.
  • History of severe renal, endocrine or hepatic diseases.
  • History of psychosis, schizophrenia, or bipolar type I.
  • History of seizure disorder.
  • Current use of over-the-counter or prescription psychoactive drugs (antidepressant, anxiolytics, antipsychotics, mood stabilizers, psychostimulants).
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  • Liver function tests (SGOT,SGPT) greater than 3 times normal.
  • Current use of modafinil
  • Current suicidality
  • Pregnancy or breast-feeding;
  • Medical contraindication to treatment with study medication (e.g. for modafinil, history of heart disease, ischemic ECG changes, arrhythmia, hypertension).
  • Women of child-bearing potential must agree to use other means of birth control and to have a pregnancy test repeated at least once monthly.
  • Known allergy to modafinil or methadone.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Department of Veterans Affairs

    West Haven, Connecticut, 06516

Other trials in United States

About this study

The purpose of this study is to compare the efficacy of the combined treatment modafinil + Contingency Management (CM) to either treatment condition alone or to yoked-controls on cocaine abstinence.

To investigate the role of modafinil-related improvements in memory, impulse control, and attention in mediating cocaine abstinence.

Read the detailed description

We hypothesize that the treatment group receiving the combination of modafinil + Contingency Management will have significantly lower cocaine use than the other treatment conditions. We also hypothesize that improvements in memory, impulse control, and attention will be a significant contributor to the treatment improvements investigated in Specific Aim #1.

Opioid and cocaine dependence are major problems among veteran and non-veterans and no effective pharmacotherapy exists for cocaine dependence. Methadone has not shown robust effectiveness in reducing cocaine abuse. Thus, new treatments are needed for the individuals who have developed cocaine dependence. This study is designed to test a new pharmacotherapy for cocaine dependence and is a placebo-controlled trial.

Being tested
Modafinil, Sugar Pill, Contingency Management, Methadone, cognitive behavioral treatment
Keywords
Treatment for addiction, Methadone given for opioid dependence, Cocaine, Opiates
Medical subject headings
Cocaine-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ModafinilDrug

    Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study.

  • Sugar PillDrug

    Also called Placebo

    placebo, sugar pill will mirror active drug

  • Contingency ManagementBehavioural

    Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample.

  • MethadoneDrug

    Subjects will be started on 30 mg of methadone and the dose will be increased as tolerated to reach 60 mg at the end of the first 1-2 weeks of the induction phase. Methadone dosing will bestabilized. During methadone maintenance (weeks 1-11 of treatment phase), subjects continue to receive their maintenance doses of methadone plus modafinil or placebo.

  • cognitive behavioral treatmentBehavioural

    All subjects will receive a manual-guided CBT treatment over the course of their 16-week participation. This manual-guided therapy promotes abstinence through a functional analysis of high-risk situations and coping skills training.

  • Voucher ControlBehavioural

    Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that they will receive vouchers according to an unpredictable schedule, and that they cannot control when they will receive these vouchers or how much they will be worth.

Study groups in NCT00838981
Study groupRoleWhat they receive
Modafinil Plus Contingency MagagementActive comparatorModafinil from 200mg up to 400mg plus Contingency Management
Receives: Drug: Modafinil; Behavioral: Contingency Management; Drug: Methadone; Behavioral: cognitive behavioral treatment
Sugar Pill Plus Contingency ManagementPlacebo comparatorPlacebo: sugar pill
Receives: Drug: Sugar Pill; Behavioral: Contingency Management; Drug: Methadone; Behavioral: cognitive behavioral treatment
Modafinil Plus Voucher ControlActive comparatorNot described
Receives: Drug: Modafinil; Drug: Methadone; Behavioral: cognitive behavioral treatment; Behavioral: Voucher Control
Sugar Pill Plus Voucher ControlPlacebo comparatorNot described
Receives: Drug: Sugar Pill; Drug: Methadone; Behavioral: cognitive behavioral treatment; Behavioral: Voucher Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average Number of Positive Urine Tests

    thrice weekly urine tests

    Measured: up to 12 weeks.

  2. Average Maximum Days Abstinent

    Measured: up to 84 days

Secondary outcomes (1)

  1. Average Number of Days Using a Substance Within Treatment

    Measured: up to 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2009 (estimated)
  2. Study startMay 2008
  3. Primary completionMar 2014
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00838981
Sponsor's protocol ID
0705002636
Other IDs
R01DA021264, DPMC
Status last verified
Dec 2021
First submitted
6 Feb 2009
Last updated
3 Dec 2021
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Modafinil, Sugar Pill and Contingency Management in people with Cocaine Dependence, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Number of Positive Urine Tests (time frame: up to 12 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00838981.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.

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