| September 16, 2005 |
| April 7, 2009 |
| March 2006 |
| July 2011 (final data collection date for primary outcome measure) |
| Substance use [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ] |
| Substance use, retention and medication compliance |
| Complete list of historical versions of study NCT00218062 on ClinicalTrials.gov Archive Site |
- Medication compliance [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]
- medication side effects [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]
|
| Cocaine craving and medication side effects |
| |
| Effectiveness of Modafinil and D-Amphetamine in Treating Cocaine Dependent Individuals |
| Pharmacotherapy Dosing Regimen (Cocaine Dependence Population) |
Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to examine the effects of d-amphetamine and modafinil, when given alone and in combination, in treating cocaine dependent individuals. |
Cocaine is a strong central nervous system stimulant that is widely abused throughout the United Sates. Due to its widespread use, it is important to develop an effective treatment for cocaine dependence. Modafinil is a glutamate-enhancing agent. D-amphetamine is a central nervous system stimulant that is approved to treat individuals with narcolepsy and attention deficit disorder. Both modafinil and d-amphetamine may be effective treatments for cocaine dependence. The purpose of this study is to examine the effectiveness of modafinil and d-amphetamine, alone and in combination, in treating cocaine dependent individuals.
This study will last 16 weeks. Participants will be randomly assigned to one of four groups: 1) 200 mg dose of modafinil; 2) 400 mg dose of modafinil; 3) 30 mg dose of d-amphetamine combined with 200 mg dose of modafinil; and 4) placebo. All participants will receive 200 mg of modafinil over 4 days. Participants assigned to the 400 mg modafinil treatment group will then receive double the initial dose of modafinil for the duration of the study. Participants in the combined group (modafinil and d-amphetamine) will receive 15 and then 30 mg of d-amphetamine over 4 days. |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Cocaine-Related Disorders |
- Drug: Dextro amphetamine sulfate and Modafinil
- Drug: modafinil
- Drug: Modafinil 400 mg
- Drug: Placebo
|
- Experimental: Modafinil 200mg
- Experimental: Modafinil 400mg
- Experimental: Modafinil 200mg/ D-Amphetamine 30mg
- Placebo Comparator: Placebo
|
| |
| |
| Recruiting |
| 200 |
| July 2012 |
| July 2011 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Meets SCID criteria for cocaine abuse or dependence
- In general good health. Individuals who are HIV-positive will not be excluded if in good general health, unless medication interactions exist.
Exclusion Criteria:
- Meets diagnostic criteria for psychiatric disorders, including other forms of drug dependence, other than nicotine
- Current cardiovascular disease, as determined by an electrocardiogram
- On probation or parole if the circumstances do not allow study completion or if ethical constraints of supervision do not allow confidentiality
- Previously received treatment with d-amphetamine, modafinil, or aripiprazole
- Currently receiving prescribed medication
|
| Both |
| 18 Years to 55 Years |
| Yes |
|
|
| United States |
| |
| NCT00218062 |
| Joy Schmitz, Ph.D., University of Texas Medical School at Houston |
| NIDA-09262-12, P50-DA009262-12, DPMC |
| National Institute on Drug Abuse (NIDA) |
| University of Texas |
| Principal Investigator: |
Joy M. Schmitz, PhD |
University of Texas |
|
|
| National Institute on Drug Abuse (NIDA) |
| April 2009 |
