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Cocaine-Related DisordersPhase 3NCT00249691

Effectiveness of Topiramate in Treating Cocaine Dependent Individuals - 1

A Phase 3 study testing Topiramate + Cognitive Behavioral Therapy in people with Cocaine-Related Disorders, run by Bankole Johnson at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Although a great amount of research has been conducted to resolve cocaine dependence, an effective treatment has yet to be discovered. Topiramate is a drug that was found to be useful in treating alcohol dependence. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cocaine-Related Disorders
What is being tested?
Topiramate + Cognitive Behavioral Therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
2 sitesUnited States
Study dates
Oct 2005to Oct 2012
Phase
Phase 3
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Current DSM-IV diagnosis of cocaine dependence
  • Good physical health as determined by a complete physical examination, an EKG within normal limits, and laboratory screening tests within acceptable parameters
  • Seeking treatment for cocaine dependence
  • At least one positive urine drug screen for cocaine at screen or baseline prior to randomization
  • If female, a negative pregnancy test prior to study entry
  • Agrees to use an effective method of contraception for the duration of the study
  • Reads and writes English
  • Willing to participate in behavioral treatment for cocaine dependence

Who cannot join

  • Current DSM-IV diagnosis of dependence on any psychoactive substance other than cocaine, alcohol, nicotine, caffeine, or marijuana
  • Physiological dependence on alcohol and requires medical detoxification
  • Neurological or psychiatric disorders
  • Any Axis 1 disorder that warrants treatment or would preclude safe participation
  • Organic brain disease
  • Dementia
Show all 30Show fewer
  • Bulimia and/or anorexia nervosa
  • Seizure disorders or epilepsy
  • Any disorder which would require ongoing treatment or which would make study agent compliance difficult
  • History of suicide attempts and/or current suicidal ideation, as determined by the SCID, within the 30 days prior to screening
  • Serious medical illnesses
  • Mandated by the court to obtain treatment for cocaine dependence
  • Expected to relocate from the study area
  • AIDS diagnosis
  • HIV with a CD4 positive T cell count less than 500 mm
  • Any subjects on any pharmacotherapy for the treatment of AIDS or HIV will be excluded
  • Active syphilis that has not been treated, or refused treatment for syphilis
  • Severe or life-threatening adverse reactions to medications (including topiramate) in the past or during this clinical trial
  • Currently receiving active treatment with topiramate
  • Use of a drug with known potential for toxicity to a major organ system (e.g., isoniazid, methotrexate), within 30 days prior to study entry
  • Pregnant or breastfeeding
  • Concurrent regular use of psychotropics, including but not limited to antidepressants, anxiolytics, antipsychotics, anticonvulsants, and psychomotor stimulant-type medications, St. John's Wort, yohimbine, ginko biloba, horehound, or any other central nervous system active herbal preparations
  • Use of any opiate substitutes (e.g., methadone, levo-alpha acetyl methadol, buprenorphine), within the month prior to screening
  • Clinically significant test results that, in the investigator's opinion, require immediate or urgent treatment
  • Fever of unknown origin or neuroleptic malignant syndrome
  • Serious medical co-morbidity requiring medical intervention or close supervision
  • Received inpatient or outpatient treatment for cocaine dependence within the 4 weeks prior to study entry
  • Past participation in a clinical trial utilizing topiramate
  • Treatment with electroconvulsive therapy within the 3 months prior to study entry
  • Member of the same household of an individual enrolled in the present study

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • UVA CARE

    Charlottesville, Virginia, 22911

  • UVA CARE Richmond

    Richmond, Virginia, 23294

Other trials in United States

About this study

Official title: Medication Development for Cocaine Dependence

Although a great amount of research has been conducted to resolve cocaine dependence, an effective treatment has yet to be discovered. Topiramate is a drug that was found to be useful in treating alcohol dependence. The purpose of this study is to determine the effectiveness of topiramate in treating cocaine dependent individuals.

Read the detailed description

Despite considerable scientific effort in the last two decades to develop treatment for cocaine dependent individuals, no medication has proven to be effective for treating cocaine dependence. Cocaine's rewarding effects are primarily a result of altering nerve pathways involving dopamine, a naturally-occurring chemical in the brain. Past research has focused on developing medications that either block dopamine or inhibit its release. However, these medications have not proven effective in treating cocaine dependence. This study will evaluate a new strategy of treating cocaine dependence by altering dopamine's functional expression. Dopamine-associated expression may be mediated through inhibition of gamma-aminobutyric acid (GABA), another brain chemical. Topiramate is a GABA inhibitor that has proven effective in treating alcohol dependent individuals. The purpose of this study is to determine the efficacy of topiramate in treating cocaine dependent individuals.

Participants will be randomly assigned to receive either 300 mg per day of topiramate or placebo. In addition, participants will receive weekly cognitive behavioral therapy for 12 weeks. Follow-up visits will occur at 2 weeks and 1, 2, and 3 months following completion of treatment, and will include evaluations of cocaine use and psychosocial functioning.

Being tested
Topiramate + Cognitive Behavioral Therapy, Placebo + Cognitive Behavioral Therapy
Keywords
cocaine addiction, cocaine dependence
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.

  • Topiramate + Cognitive Behavioral TherapyDrug

    Also called Topamax

    Topiramate up to 300 mg per day

  • Placebo + Cognitive Behavioral TherapyDrug

    Also called Sugar Pill

    Placebo twice a day

Study groups in NCT00249691
Study groupRoleWhat they receive
TopiramateExperimentalNot described
Receives: Drug: Topiramate + Cognitive Behavioral Therapy
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo + Cognitive Behavioral Therapy

What is being measured

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

  1. Effectiveness of topiramate to reduce cocaine use(assessed by a combination of self-report of use and urine assays for benzoylecgonine, the major metabolite of cocaine).

    Measured: Throughout the study (Visit 0 to Visit 12, and at 2 weeks, 1, 2, and 3 months following completion of treatment)

Secondary outcomes (1)

  1. Improved psychosocial functioning; measured throughout the study, and at 2 weeks and 1, 2, and 3 months following completion of treatment

    Measured: measured throughout the study, and at 2 weeks and 1, 2, and 3 months following completion of treatment

Timeline

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

  1. First posted7 Nov 2005 (estimated)
  2. Study startOct 2005
  3. Primary completionOct 2011
  4. Study completionOct 2012 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00249691
Sponsor's protocol ID
11578
Other IDs
R01DA017296, DPMC
Status last verified
Mar 2012
First submitted
3 Nov 2005
Last updated
8 Mar 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Khalifa NR, Gibbon S, Vollm BA, Cheung NH, McCarthy L. Pharmacological interventions for antisocial personality disorder. Cochrane Database Syst Rev. 2020 Sep 3;9(9):CD007667. doi: 10.1002/14651858.CD007667.pub3.

    PubMed 32880105

  • Johnson BA, Ait-Daoud N, Wang XQ, Penberthy JK, Javors MA, Seneviratne C, Liu L. Topiramate for the treatment of cocaine addiction: a randomized clinical trial. JAMA Psychiatry. 2013 Dec;70(12):1338-46. doi: 10.1001/jamapsychiatry.2013.2295.

    PubMed 24132249

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Topiramate + Cognitive Behavioral Therapy in people with Cocaine-Related Disorders, run by Bankole Johnson at 2 sites 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 8 inclusion and 30 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: status not confirmed, as of the sponsor's last update on 8 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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?

Effectiveness of topiramate to reduce cocaine use(assessed by a combination of self-report of use and urine assays for benzoylecgonine, the major metabolite of cocaine). (time frame: Throughout the study (Visit 0 to Visit 12, and at 2 weeks, 1, 2, and 3 months following completion of treatment)). 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 NCT00249691, which also lists 2 linked publications.

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 8 Mar 2012.

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