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Combined Pharmaco/Behavior Therapy in Adolescent Smokers

7 septembre 2018 mis à jour par: Kevin Gray, MD, Medical University of South Carolina

In the current proposal, we intend to study the efficacy of bupropion SR with or without combined contingency management (CM) among adolescent cigarette smokers. The proposed study will test not only medication (bupropion SR), but also combination of medication and CM in potentially improving smoking cessation outcomes AND retention of adolescent smokers in the study.

Hypothesis to be tested: Bupropion SR treatment will increase abstinence from cigarette smoking (as measured by urine cotinine and continuous abstinence) in adolescent smokers as compared to treatment with placebo only.

Hypothesis to be tested: Adolescent smokers treated with combined bupropion SR + contingency management (CM) treatment will have increased retention and increased abstinence rates when compared to bupropion SR alone or CM + placebo treated groups (as measured by decreased drop-out of participants, urine cotinine and continuous abstinence).

Hypothesis to be tested: CM will increase the abstinence from cigarette smoking (as measured by urine cotinine and continuous abstinence) in adolescent smokers as compared to treatment with placebo only.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

To test the hypotheses, 216 adolescent smokers will be recruited. Fifty-four adolescent smokers will be recruited in each of the four groups: bupropion SR only, bupropion SR + CM, CM + placebo, and placebo only. The cells will be balanced for gender and attention deficit hyperactivity disorder using permuted block randomization. A counseling intervention was added for all groups because it was reasoned that it would be unethical not to provide an active treatment to cigarette smoking adolescents. The counseling intervention will consist of two quit smoking brochures that provide information on tips to help quit smoking.

The study will consist of a one-week lead in period followed by a six-week treatment trial. For the medication groups, medications will be titrated during the one-week lead-in period. The primary outcome measure is urine cotinine and self-report of cigarette use collected using the Time-Line Follow-Back at the end of six weeks.

Type d'étude

Interventionnel

Inscription (Réel)

134

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • South Carolina
      • Charleston, South Carolina, États-Unis, 29425
        • Medical University of South Carolina

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

12 ans à 21 ans (Enfant, Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  1. Regular cigarette smokers smoking at least 5 cigarettes per day as derived by Time-Line Follow-Back method (Sobell et al., 1988). Average number of cigarettes per day (over past 30 days) will be used. Five cigarettes per day may seem low, but based on previous studies, adolescents tend to smoke fewer cigarettes per day as compared to adults.
  2. Baseline urine cotinine level greater than 100 ng/ml.
  3. Age range of 12 - 21
  4. If under 18 yr. of age, parent(s) or guardian(s) able to participate in informed consent and initial assessment, or the participant must provide evidence of emancipated status.
  5. For post menarchal female participants: agree to use birth control to avoid pregnancy.

Exclusion Criteria:

  1. Active substance abuse/dependence (other than nicotine) within 2 weeks prior to participating in the study
  2. Lifetime bipolar affective disorder (BPAD), psychosis, eating disorders. Bupropion may have adverse consequence on participants with these psychiatric diagnoses.
  3. Current major depressive disorders. Since bupropion is also an antidepressant, this criteria is to minimize the confound of depressive disorder during the study. History of depressive disorders and current attention deficit hyperactivity disorder (ADHD) will not be an exclusion. We will use permuted block randomization procedure to balance the groups for ADHD.
  4. Pregnancy or lactation. The safety of bupropion in pregnancy and during lactation is not well studied.
  5. History of seizure disorder or predisposition to seizures (e.g., history of significant head trauma, currently taking medications that lower seizure threshold), since bupropion can lower seizure threshold.
  6. History of severe renal, hepatic, neurological, or chronic pulmonary disease. This criterion was chosen due to the hepatic metabolism of bupropion.
  7. Unstable medical problems
  8. Allergy to bupropion
  9. Current treatment with any other medication containing bupropion
  10. Current treatment with any monoamine oxidase (MAO) inhibitors currently or within 2 weeks of starting the study since there may be serious and severe medical interactions between MAO inhibitors and bupropion SR.
  11. Current treatment with nicotine replacement therapy (NRT)
  12. History of intolerance or non-response to bupropion SR.
  13. Current (past month) suicide ideation
  14. Suicide attempt (past year)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Bupropion SR + Contingency Management
Bupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management, with escalating rewards for abstinence (and re-sets for non-abstinence) at twice-weekly visits.
Médicament: Bupropion SR
Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment
Comportemental: Contingency Management
Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence.
Comparateur actif: Placebo + Contingency Management
Placebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management, with escalating rewards for abstinence (and re-sets for non-abstinence) at twice-weekly visits.
Comportemental: Contingency Management
Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence.
Autre: Placebo
Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment
Comparateur actif: Bupropion SR + No Contingency Management
Bupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management is not provided in this arm.
Médicament: Bupropion SR
Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment
Comparateur placebo: Placebo + No Contingency Management
Placebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management is not provided in this arm.
Autre: Placebo
Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Biologically-verified 7-day Point Prevalence Smoking Abstinence
Délai: End of treatment (week 6)
Self-reported abstinence for the past 7 days, confirmed by urine cotinine ≤100 ng/mL
End of treatment (week 6)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Medical University of South Carolina

Collaborateurs

National Institute on Drug Abuse (NIDA)

Les enquêteurs

  • Chercheur principal: Himanshu P Upadhyaya, MS, MBBS, Medical University of South Carolina

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mars 2004

Achèvement primaire (Réel)

1 juillet 2009

Achèvement de l'étude (Réel)

1 juillet 2009

Dates d'inscription aux études

Première soumission

25 mai 2006

Première soumission répondant aux critères de contrôle qualité

25 mai 2006

Première publication (Estimation)

26 mai 2006

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 octobre 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 septembre 2018

Dernière vérification

1 septembre 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • DA17460
  • R01DA017460 (Subvention/contrat des NIH des États-Unis)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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